HealthyPhase 1NCT00840099
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
A Phase 1 study testing 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL and Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL and Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Aug 2002
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of age and over.
- Body weight within ±15% of the appropriate weight range published in 1993 by Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less than 30.
- Negative for:
- HIV
- Hepatitis B and C
- Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
Show all 14Show fewer
- Cotinine (urine test)
- Breath alcohol (Breathalyzer)
- HCG (females only)
- No significant diseases or clinically significant abnormal laboratory values.
- No clinically significant findings in the physical examination.
- No clinically significant findings in vital sign measurements and 12-lead electrocardiogram (ECG).
- Informed of the nature of the study and give written consent prior to receiving any study medication.
- Female subjects: surgically steril, post-menopausal or practicing a recognized safe method of contraception (abstention, oral or implanted contraceptives, intra-uterine device or consistent condom plus spermicide use).
Who cannot join
- Known history or presence of any disease or condition which might compromise the following body systems: immunologic, endocrine, renal, cardiovascular, respiratory, hematologic, gastrointestinal, neurologic, hepatic, psychiatric or dermatologic
- More specifically: history or presence of significant: sensitivity to multiple allergens, diarrhea, stomach or intestinal disease, mononucleosis, renal or hepatic dysfunction and asthma.
- Known or suspected carcinoma.
- Known history or presence of:
- Hypersensitivity or idiosyncratic reaction to amoxicillin, clavulanic acid, penicillins, cephalosporins and/or any other β-lactamase inhibitors.
- Clavulin-associated jaundice/hepatic dysfunction.
Show all 14Show fewer
- Alcoholism within last 12 months.
- Drug dependence and/or substance abuse.
- Use of tobacco or nicotine-containing products, within last 12 months.
- On a special diet within 4 weeks prior to drug administration (i.e. a deliberate change in diet for any reason).
- Participation in another clinical trial or received an investigational product in the previous 30 days prior to drug administration.
- Donation up to 250 mK of blood in the previous 30 days, 251-500 mKL in the previous 45 days, 501-750 mL in the previous 60 days or above 750 mL in the previous 90 days prior to study start.
- Requirement of any medication, (prescription and/or over-the-counter) or dietary supplements on a routine basis, with the exception of occasional use of acetaminophen and oral or implanted contraceptives.
- Difficulty fasting or consuming the standard prescribed meals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL, Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mLDrug
1 x 600 mg/42.9 mg/5 mL, single-dose fed
Augmentin ES-600™ 600 mg/42.9 mg/5 mL SuspensionDrug
1 x 600 mg/42.9 mg/5 mL, single-dose fed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL |
| 2 | Active comparator | Not described Receives: Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence Based on Cmax for Amoxicillin
Cmax - Maximum Observed Concentration
Measured: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Amoxicillin
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Amoxicillin
AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration
Measured: Blood samples collected over 14 hour period
Bioequivalence Based on Cmax for Clavulanic Acid
Cmax - Maximum Observed Concentration
Measured: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Clavulanic Acid
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Clavulanic Acid
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Measured: Blood samples collected over 14 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startAug 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xueyu (Eric) Chen, M.D., Ph. D., Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840099
- Sponsor's protocol ID
- 02-543
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2009
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00840099
- Acronym / sponsor ID
- 02-543
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Posted 25 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL |
| 2 | Active comparator | Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of age and over.
- Body weight within ±15% of the appropriate weight range published in 1993 by Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less than 30.
- Negative for:
- No significant diseases or clinically significant abnormal laboratory values.
- No clinically significant findings in the physical examination.
Key exclusion criteria (14 listed)
- Known history or presence of any disease or condition which might compromise the following body systems: immunologic, endocrine, renal, cardiovascular, respiratory, hematologic, gastrointestinal, neurologic, hepatic, psychiatric or dermatologic
- More specifically: history or presence of significant: sensitivity to multiple allergens, diarrhea, stomach or intestinal disease, mononucleosis, renal or hepatic dysfunction and asthma.
- Known or suspected carcinoma.
- Known history or presence of:
- On a special diet within 4 weeks prior to drug administration (i.e. a deliberate change in diet for any reason).
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 |
|---|---|---|
| 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL1 x 600 mg/42.9 mg/5 mL, single-dose fed | Drug | 1 |
| Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension1 x 600 mg/42.9 mg/5 mL, single-dose fed | Drug | 2 |
Primary outcome
Bioequivalence Based on Cmax for Amoxicillin
Time frame: Blood samples collected over 14 hour period
Cmax - Maximum Observed Concentration
Bioequivalence Based on AUC0-inf for Amoxicillin
Time frame: Blood samples collected over 14 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence Based on AUC0-t for Amoxicillin
Time frame: Blood samples collected over 14 hour period
AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration
Bioequivalence Based on Cmax for Clavulanic Acid
Time frame: Blood samples collected over 14 hour period
Cmax - Maximum Observed Concentration
Bioequivalence Based on AUC0-inf for Clavulanic Acid
Time frame: Blood samples collected over 14 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence Based on AUC0-t for Clavulanic Acid
Time frame: Blood samples collected over 14 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
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.
Xueyu (Eric) Chen, M.D., Ph. D. principal investigator
Pharma Medica Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL and Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
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 14 inclusion and 14 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 20 Aug 2024. 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 Canada. 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.
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?
Yes. Results are posted in the registry (first posted 25 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bioequivalence Based on Cmax for Amoxicillin (time frame: Blood samples collected over 14 hour period). The study lists 6 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 20 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.