Drug UseNCT04982861
Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers
A study testing Cefixime Trihydrate 100 mg/5 mL Dry Syrup and Suprax 100 MG in 5 mL Oral Suspension in people with Drug Use, run by PT Bernofarm at 1 site in Indonesia.
Trial summary
This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Cefixime Trihydrate 100 mg/5 mL Dry Syrup and Suprax 100 MG in 5 mL Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jun 2020to 25 Aug 2020
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- Had read the subject information and signed informed consent documents
- Age 18 - 55 years
- Body mass index between 18-25 kg/m2
- Had a normal electrocardiogram
- Blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
- Heart rate within normal range (60-100 bpm)
- The absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
Who cannot join
- those who were pregnant and/or nursing women.
- those who had a history of contraindication or hypersensitivity to cefixime, other antibiotics or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction
- those who had a history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, and cardiovascular disease.
- those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
- those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day.
- those who had participated in any clinical study within 3 months prior to the study (< 90 days).
Show all 15Show fewer
- those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
- those who smoked more than 10 cigarettes a day.
- those who had a history of traveling to another city within the last 14 days
- those with a history of direct contact with a COVID-19 positive person in the subject neighborhood
- those with a history or presence of sore throat, fever (with temperature more than 37°C) or short of breath within the last 14 days
- those who were positive to COVID-19
- those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
- those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
- those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, poor venous access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Cefixime Trihydrate 100 mg/5 mL DS in Indonesia Healthy Volunteers
This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.
Read the detailed description
Twenty two healty subjects were given a single dose of 100 mg/5 mL cefixime trihydrate dry syrup or or 100 mg/5 mL Suprax® dry syrup with 240 mL of water. Then the blood samples for cefixime trihydrate was drawn and analyzed using HPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation.
- Conditions
- Drug Use
- Being tested
- Cefixime Trihydrate 100 mg/5 mL Dry Syrup, Suprax 100 MG in 5 mL Oral Suspension
- Keywords
- bioequivalence study, cefixime trihydrate, dry syrup, Indonesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefixime Trihydrate 100 mg/5 mL Dry SyrupDrug
Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water
Suprax 100 MG in 5 mL Oral SuspensionDrug
Also called Cefixime Trihydrate 100 mg/5 mL Dry Syrup
Participants received a single dose of 5 mL of Suprax with 240 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Cefixime trihydrate 100 mg/5 mL dry syrup | Experimental | Cefixime trihydrate 100 mg/5 mL dry syrup was dissolved by 20 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. Receives: Drug: Cefixime Trihydrate 100 mg/5 mL Dry Syrup |
| Suprax® 100 mg/5 mL dry syrup | Active comparator | Suprax® 100 mg/5 mL dry syrup was dissolved by 33 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. Receives: Drug: Suprax 100 MG in 5 mL Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio
The ratio between test drug and reference drug
Measured: 32 hours
90% confidence intervals
The two products are considered bioequivalent when the 90% confidence intervals of the cefixime trihydrate geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax.
Measured: 32 hours
Secondary outcomes (2)
Pharmacokinetics parameter
Maximum plasma concentration (Cmax)
Measured: 32 hours
Pharmacokinetics parameter
Area Under Curve from 0 to 32 hours (AUCt)
Measured: pre-dose at (0 h) and post dose at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start15 Jun 2020
- Primary completion15 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bernofarm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Responsible party
- Sponsor
- Investigators
- I Gusti Putu Bagus Diana Virgo, Study director, PT Pharma Metric Labs, IndonesiaArini Setiawati, Principal investigator, PT Pharma Metric Labs, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982861
- Sponsor's protocol ID
- 432/STD/PML/2018
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asiri YA, Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Yamani MJ, Alsarra IA, Al-Balla SA. Comparative bioavailability study of cefixime (equivalent to 100 mg/5 ml) suspension (Winex vs Suprax) in healthy male volunteers. Int J Clin Pharmacol Ther. 2005 Oct;43(10):499-504. doi: 10.5414/cpp43499.
PubMed 16240707Kees F, Naber KG, Sigl G, Ungethum W, Grobecker H. Relative bioavailability of three cefixime formulations. Arzneimittelforschung. 1990 Mar;40(3):293-7.
PubMed 2346538Morais JA, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):221-5. doi: 10.1111/j.1742-7843.2009.00518.x. Epub 2010 Jan 7.
PubMed 20070293
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Cefixime Trihydrate 100 mg/5 mL DS in Indonesia Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04982861
- Acronym / sponsor ID
- 432/STD/PML/2018
- Conditions
- Drug Use
- Keywords
- bioequivalence study, cefixime trihydrate, dry syrup, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- PT BernofarmIndustry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 29 Jul 2021 (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.
This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.
Detailed description
Twenty two healty subjects were given a single dose of 100 mg/5 mL cefixime trihydrate dry syrup or or 100 mg/5 mL Suprax® dry syrup with 240 mL of water. Then the blood samples for cefixime trihydrate was drawn and analyzed using HPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.
| Arm | Type | Receives |
|---|---|---|
| Cefixime trihydrate 100 mg/5 mL dry syrup | Experimental | Drug: Cefixime Trihydrate 100 mg/5 mL Dry SyrupCefixime trihydrate 100 mg/5 mL dry syrup was dissolved by 20 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. |
| Suprax® 100 mg/5 mL dry syrup | Active comparator | Drug: Suprax 100 MG in 5 mL Oral SuspensionSuprax® 100 mg/5 mL dry syrup was dissolved by 33 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female subjects
- Had read the subject information and signed informed consent documents
- Age 18 - 55 years
- Body mass index between 18-25 kg/m2
- Had a normal electrocardiogram
Key exclusion criteria (15 listed)
- those who were pregnant and/or nursing women.
- those who had a history of contraindication or hypersensitivity to cefixime, other antibiotics or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction
- those who had a history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, and cardiovascular disease.
- those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
- those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day.
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 Trihydrate 100 mg/5 mL Dry SyrupParticipants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water | Drug | Cefixime trihydrate 100 mg/5 mL dry syrup |
| Suprax 100 MG in 5 mL Oral SuspensionAlso: Cefixime Trihydrate 100 mg/5 mL Dry SyrupParticipants received a single dose of 5 mL of Suprax with 240 mL of water | Drug | Suprax® 100 mg/5 mL dry syrup |
Primary outcome
Geometric Mean Ratio
Time frame: 32 hours
The ratio between test drug and reference drug
90% confidence intervals
Time frame: 32 hours
The two products are considered bioequivalent when the 90% confidence intervals of the cefixime trihydrate geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax.
2 secondary outcomes
Pharmacokinetics parameter
Time frame: 32 hours
Pharmacokinetics parameter
Time frame: pre-dose at (0 h) and post dose at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 16240707Asiri YA, Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Yamani MJ, Alsarra IA, Al-Balla SA. Comparative bioavailability study of cefixime (equivalent to 100 mg/5 ml) suspension (Winex vs Suprax) in healthy male volunteers. Int J Clin Pharmacol Ther. 2005 Oct;43(10):499-504. doi: 10.5414/cpp43499.
- Background: PubMed 2346538Kees F, Naber KG, Sigl G, Ungethum W, Grobecker H. Relative bioavailability of three cefixime formulations. Arzneimittelforschung. 1990 Mar;40(3):293-7.
- Background: PubMed 20070293Morais JA, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):221-5. doi: 10.1111/j.1742-7843.2009.00518.x. Epub 2010 Jan 7.
- Clinical Pharmacology and Biopharmaceutic ReviewLink provided by the sponsor.
- Guideline For Good Clinical PracticeLink provided by the sponsor.
Related trials for Drug Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
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.
I Gusti Putu Bagus Diana Virgo study director
PT Pharma Metric Labs, Indonesia
Arini Setiawati principal investigator
PT Pharma Metric Labs, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefixime Trihydrate 100 mg/5 mL Dry Syrup and Suprax 100 MG in 5 mL Oral Suspension in people with Drug Use, run by PT Bernofarm at 1 site in Indonesia.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Geometric Mean Ratio (time frame: 32 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982861, which also lists 3 linked publications.
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 11 Aug 2021.