HealthyPhase 1NCT00836901
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
A Phase 1 study testing amoxicillin-clavulanic acid and Augmentin® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed 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?
- amoxicillin-clavulanic acid and Augmentin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Sep 2003
- 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
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
Who cannot join
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive urine drug screen at screening.
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- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.
- Subjects with BMI ≥30.0.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid or other related drugs (e.g. penicillin, cephalosporins, cephamycins).
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid) use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Subinvestigator, contraindicate the subject's participation in this study.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products )including natural products, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
- less than 300 mL of whole blood within 30 days, or
- 300 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days.
- Positive alcohol breath test at screening.
- Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
- Intolerance to venipunctures.
- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
- Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction
- Any known active mononucleosis
- Subjects with dentures or braces.
- Additional exclusion criteria for female subjects only:
- Breast feeding subjects.
- Positive urine pregnancy test at screening (performed on all females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- amoxicillin-clavulanic acid, Augmentin®
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin-clavulanic acidDrug
400 mg-57 mg chewable tablet
Augmentin®Drug
400 mg-57 mg chewable tablet
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin Calvulanic Acid | Experimental | Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 40-57 mg Chewable Tablet (reference) dosed in second period Receives: Drug: amoxicillin-clavulanic acid |
| Augmentin® | Active comparator | Augmentin® 400-57 mg Chewable Tablet (test) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (reference) dosed in second period Receives: Drug: Augmentin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Observed Concentration) - Amoxicillin
Bioequivalence based on Cmax
Measured: Blood samples collected over 10 hour period
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 10 hour period
AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 10 hour period
Cmax (Maximum Observed Concentration) - Clavulanic Acid
Bioequivalence based on Cmax
Measured: Blood samples were collected over 10 hour period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 10 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 10 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startSep 2003
- Primary completionSep 2003
- Study completionSep 2003
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Larouche, MD, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836901
- Sponsor's protocol ID
- 30074
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2009
- Last updated
- 21 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00836901
- Acronym / sponsor ID
- 30074
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 18 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 compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin Calvulanic Acid | Experimental | Drug: amoxicillin-clavulanic acidAmoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 40-57 mg Chewable Tablet (reference) dosed in second period |
| Augmentin® | Active comparator | Drug: Augmentin®Augmentin® 400-57 mg Chewable Tablet (test) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (reference) dosed in second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
Key exclusion criteria (33 listed)
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 |
|---|---|---|
| amoxicillin-clavulanic acid400 mg-57 mg chewable tablet | Drug | Amoxicillin Calvulanic Acid |
| Augmentin®400 mg-57 mg chewable tablet | Drug | Augmentin® |
Primary outcome
Cmax (Maximum Observed Concentration) - Amoxicillin
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on Cmax
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-inf
AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-t
Cmax (Maximum Observed Concentration) - Clavulanic Acid
Time frame: Blood samples were collected over 10 hour period
Bioequivalence based on Cmax
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-inf
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-t
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Larouche, MD principal investigator
Anapharm
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 amoxicillin-clavulanic acid and Augmentin® 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 1 inclusion and 33 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 21 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 18 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?
Cmax (Maximum Observed Concentration) - Amoxicillin (time frame: Blood samples collected over 10 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 21 Aug 2024.