Infections, BacterialPhase 1NCT03329547
A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions
A Phase 1 study testing Cefixime test capsule and Cefixime reference capsule in people with Infections, Bacterial, run by GlaxoSmithKline.
Trial summary
Cefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Bacterial
- What is being tested?
- Cefixime test capsule and Cefixime reference capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2018to 2 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight within >=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m^2) (inclusive).
- Healthy male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
- Capable of giving signed informed consent.
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
- Abnormal blood pressure as determined by the investigator.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
Show all 26Show fewer
- ALT >1.5x upper limit of normal (ULN).
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of colitis.
- History of cephalosporin induced hemolytic anemia.
- QT interval corrected for heart rate according to Bazett's formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded.
- Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 90 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.
- Presence of Hepatitis B surface antigen (HBsAg) at screening. Positive Hepatitis C antibody test result at screening.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months prior to screening.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Known sensitivity to any drugs from the class of cephalosporin, or components thereof.
- Known sensitivity to any drugs from the class of penicillin, or components thereof.
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that contraindicates participation in the study.
About this study
Official title: An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of SKF101804 Cefixime 400 mg Capsule Versus Cefixime 400 mg Capsule Reference Product in Healthy Adult Participants Under Fasting Conditions
Cefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis. Cefixime acts by inhibiting the action of proteins involved in the synthesis of bacterial cell walls, which leads to bacterial cell lysis and cell death. Due to lack of bioequivalence between tablet/capsule and suspension formulation of cefixime, consideration needs to be given if the oral suspension is to be substituted for the tablet/capsule. This study is designed to assess whether test SKF101804 cefixime 400 milligrams (mg) capsule is bioequivalent to reference cefixime 400 mg capsule under fasting conditions in healthy adults. Subjects will be randomized in crossover manner to receive single oral doses of treatment A (SKF101804 cefixime test capsules) and treatment B (reference cefixime capsules), followed by a washout period of 7-14 days. Approximately 26 subjects will be included in the study and total duration in the study for each subject will be approximately 5 to 7 weeks.
- Conditions
- Infections, Bacterial
- Being tested
- Cefixime test capsule, Cefixime reference capsule
- Keywords
- Bioequivalence, Pharmacokinetics, SKF101804, Crossover, Cefixime
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefixime test capsuleDrug
SKF101804/cefixime test capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as a dark purple head and off white body locking type capsule with "GSK' printed on cap and "400MG" printed on body of capsule.
Cefixime reference capsuleDrug
Cefixime reference capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as red/orange hard gelatin size 0 capsule with "Cefspan 400 mg" printed on body of capsule.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence AB | Experimental | Eligible subjects will receive treatment sequence AB; A= SKF101804 cefixime 400 mg test capsules and B= cefixime 400 mg reference capsules. Subjects will receive single oral dose of treatment A in treatment period 1 on Day 1 and treatment B in treatment period 2 on Day 1. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. Receives: Drug: Cefixime test capsule; Drug: Cefixime reference capsule |
| Subjects receiving treatment sequence BA | Experimental | Eligible subjects will receive treatment sequence BA; B= cefixime 400 mg reference capsules and A= SKF101804 cefixime 400 mg test capsules. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. Subjects will receive single oral dose of treatment B in treatment period 1 on Day 1 and A in treatment period 2 on Day 1. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. Receives: Drug: Cefixime test capsule; Drug: Cefixime reference capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
AUC (0-t) of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Maximum observed concentration (Cmax) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Cmax of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Secondary outcomes (16)
AUC from time zero extrapolated to infinite time (AUC [0-infinity]) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
AUC(0-infinity) of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Time of occurrence of Cmax (Tmax) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Tmax of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Percentage of AUC (0-infinity) obtained by extrapolation (percent AUCex) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsule under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Percent AUCex obtained by extrapolation of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Apparent terminal phase half-life (T1/2) of cefixime test capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsule under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
T1/2 of cefixime reference capsule
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Measured: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Number of subjects with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Measured: Up to 27 days
Number of subjects with serious AEs (SAEs)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Measured: Screening and up to 27 days
Number of subjects with abnormal hematology laboratory parameters as a measure of safety
Hematology parameters will be analyzed including platelet count, red blood cells (RBC) count, hemoglobin and hematocrit level as a measure of safety.
Measured: Up to 27 days
Number of subjects with abnormal biochemistry laboratory parameters as a measure of safety
Biochemistry parameters will be analyzed including blood urea nitrogen (BUN), fasting glucose, potassium, creatinine, sodium, calcium, aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total and direct bilirubin and total protein as a measure of safety.
Measured: Up to 27 days
Number of subjects with abnormal values for body temperature
Body temperature will be measured in a semi-supine position after at least a 5-min rest.
Measured: Up to 27 days
Number of subjects with abnormal pulse rate
Pulse rate will be measured in a semi-supine position after 5-min rest.
Measured: Up to 27 days
Number of subjects with abnormal respiratory rate
Respiratory rate will be measured in a semi-supine position after at least a 5-min rest.
Measured: Up to 27 days
Number of subjects with abnormal values for blood pressure
Systolic and diastolic blood pressure will be measured in a supine position after 5 minutes rest.
Measured: Up to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start11 Jan 2018 (estimated)
- Primary completion2 Feb 2018 (estimated)
- Study completion2 Feb 2018 (estimated)
Why it stopped: Change in commercial strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a two-period crossover study. Subjects will receive single oral dose of cefixime 400 mg test capsules and cefixime 400 mg reference capsules in treatment period 1 and 2 under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329547
- Sponsor's protocol ID
- 205732
- Status last verified
- Mar 2018
- First submitted
- 30 Oct 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of SKF101804 Cefixime 400 mg Capsule Versus Cefixime 400 mg Capsule Reference Product in Healthy Adult Participants Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03329547
- Acronym / sponsor ID
- 205732
- Conditions
- Infections, Bacterial
- Keywords
- Bioequivalence, Pharmacokinetics, SKF101804, Crossover, Cefixime
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in commercial strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2018 (estimated)
- Primary completion
- 2 Feb 2018 (estimated)
- Study completion
- 2 Feb 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis. Cefixime acts by inhibiting the action of proteins involved in the synthesis of bacterial cell walls, which leads to bacterial cell lysis and cell death. Due to lack of bioequivalence between tablet/capsule and suspension formulation of cefixime, consideration needs to be given if the oral suspension is to be substituted for the tablet/capsule. This study is designed to assess whether test SKF101804 cefixime 400 milligrams (mg) capsule is bioequivalent to reference cefixime 400 mg capsule under fasting conditions in healthy adults. Subjects will be randomized in crossover manner to receive single oral doses of treatment A (SKF101804 cefixime test capsules) and treatment B (reference cefixime capsules), followed by a washout period of 7-14 days. Approximately 26 subjects will be included in the study and total duration in the study for each subject will be approximately 5 to 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a two-period crossover study. Subjects will receive single oral dose of cefixime 400 mg test capsules and cefixime 400 mg reference capsules in treatment period 1 and 2 under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence AB | Experimental | Drug: Cefixime test capsule, Drug: Cefixime reference capsuleEligible subjects will receive treatment sequence AB; A= SKF101804 cefixime 400 mg test capsules and B= cefixime 400 mg reference capsules. Subjects will receive single oral dose of treatment A in treatment period 1 on Day 1 and treatment B in treatment period 2 on Day 1. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. |
| Subjects receiving treatment sequence BA | Experimental | Drug: Cefixime test capsule, Drug: Cefixime reference capsuleEligible subjects will receive treatment sequence BA; B= cefixime 400 mg reference capsules and A= SKF101804 cefixime 400 mg test capsules. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. Subjects will receive single oral dose of treatment B in treatment period 1 on Day 1 and A in treatment period 2 on Day 1. Treatment periods 1 and 2 will be separated by a washout period of 7 to 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight within >=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m^2) (inclusive).
- Healthy male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
Key exclusion criteria (26 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
- Abnormal blood pressure as determined by the investigator.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefixime test capsuleSKF101804/cefixime test capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as a dark purple head and off white body locking type capsule with "GSK' printed on cap and "400MG" printed on body of capsule. | Drug | Subjects receiving treatment sequence AB, Subjects receiving treatment sequence BA |
| Cefixime reference capsuleCefixime reference capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as red/orange hard gelatin size 0 capsule with "Cefspan 400 mg" printed on body of capsule. | Drug | Subjects receiving treatment sequence AB, Subjects receiving treatment sequence BA |
Primary outcome
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
AUC (0-t) of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
Maximum observed concentration (Cmax) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Blood samples will be collected for pharmacokinetic analysis of cefixime test capsules under fasting conditions.
Cmax of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Blood samples will be collected for pharmacokinetic analysis of cefixime reference capsules under fasting conditions.
16 secondary outcomes
AUC from time zero extrapolated to infinite time (AUC [0-infinity]) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
AUC(0-infinity) of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Time of occurrence of Cmax (Tmax) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Tmax of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Percentage of AUC (0-infinity) obtained by extrapolation (percent AUCex) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Percent AUCex obtained by extrapolation of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Apparent terminal phase half-life (T1/2) of cefixime test capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
T1/2 of cefixime reference capsule
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose
Number of subjects with adverse events (AEs)
Time frame: Up to 27 days
Number of subjects with serious AEs (SAEs)
Time frame: Screening and up to 27 days
Number of subjects with abnormal hematology laboratory parameters as a measure of safety
Time frame: Up to 27 days
Number of subjects with abnormal biochemistry laboratory parameters as a measure of safety
Time frame: Up to 27 days
Number of subjects with abnormal values for body temperature
Time frame: Up to 27 days
Number of subjects with abnormal pulse rate
Time frame: Up to 27 days
Number of subjects with abnormal respiratory rate
Time frame: Up to 27 days
Number of subjects with abnormal values for blood pressure
Time frame: Up to 27 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Heart Valve Diseases, Aortic Valve Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefixime test capsule and Cefixime reference capsule in people with Infections, Bacterial, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) of cefixime test capsule (time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.00 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.