HealthyNCT00778414
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg - 42.9 mg/ 5 mL Oral Suspension Under Fasting Conditions
A study testing Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, 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?
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 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
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Sep 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, SFBC Anapharm Web site, SFBC Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:
- Male or female, smoker or non - smoker, 18 years of age or older
- Capable of consent
- BMI should be greater than, or equal to 19.0 and less than 30.0
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illness or surgery within 4 weeks prior to dosing
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Any reason which, in the opinion of the Clinical Sub - Investigator, would prevent the subjects from participating in the study
- Positive test 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, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening
Show all 24Show fewer
- History of significant alcohol abuse or drug abuse within one year prior to the screening
- Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [ 1 unit = 150 mL of wine, 360 mL of beer, 0r 45 mL of 40% alcohol])
- Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening
- History of allergic reactions to amoxicillin - clavulanic acid, penicillin, or other related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, Omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolines, antihistamines) within 30 days prior to administration of the study medication
- Use of an investigational drug or participation in an investigational study within 30 days prior to dosing
- Clinically significant history or presence of any 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 neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease
- Use of the prescription medication within 14 days prior to the administration of study medication or over - the - counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to the administration of the study medication, except for topical products without systemic absorption and hormonal contraceptives
- Difficulty to swallow the study medication
- Smoking more than 25 cigarettes per days
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Clinical Sub-Investigator, could contraindicate the subject's participation in this study
- A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of the study medications
- Donation of plasma (500 mL) within 7 days prior to the drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures for this study) prior to administration of the study medication as follows:
- 50 mL to 599 mL of whole blood within 30 days
- More than 499 ml of whole blood within 56 days prior to the drug administration t) Wear of dentures or presence of braces at the time of dosing or any piercing in mouth, lips, and/ or tongue u) Positive urine pregnancy test at screening v) Breast feeding subject w) Female subjects of child bearing potential having unprotected sexual intercourse with any non - sterile male partner (i.e. male who have not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Hormonal contraceptives are permitted during the study but are not an acceptable method of contraception. Acceptable methods of contraception are:
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration)
- Condom or diaphragm + spermicide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open - Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600mg - 42.9 mg/ 5 mL Oral Suspension and Augmentin ES - 600 (Reference) Following a 600 mg - 42.9 mg Dose in Healthy Subjects Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, under fasting conditions.
Read the detailed description
This was a single center, randomized, single-dose, open-label, 2 - way crossover bioequivalence study to compare the rate and extent of absorption of a test amoxicillin - clavulanic acid versus Augmentin ES - 600, a reference amoxicillin - clavulanic acid, under fasting condition. Prior to study commencement, subjects were randomly assigned to a treatment in accordance with the randomization scheme generated by Anapharm. Subjects were confined to the Anapharm Clinical Research Facility from at least 10 hours prior to the drug administration until after the 12 - hour post dose blood draw, in each period. The treatment phases were separated by a washout period of 20 days.
A total of 55 healthy, adult subjects signed the study - specific Informed Consent Form and were confined for Period I; of these subjects, 48 (24 males and 24 females) were enrolled and were dosed in the study; 42 of these enrolled subjects completed the study.
- Conditions
- Healthy
- Being tested
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension
- Keywords
- Bioequivalence Amoxicillin Clavulanic acid 600mg 42.9 mg per 5 mL oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension of ranbaxy Receives: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension |
| 2 | Active comparator | Augmentin ES - 600 Receives: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778414
- Sponsor's protocol ID
- 60249
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open - Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600mg - 42.9 mg/ 5 mL Oral Suspension and Augmentin ES - 600 (Reference) Following a 600 mg - 42.9 mg Dose in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00778414
- Acronym / sponsor ID
- 60249
- Conditions
- Healthy
- Keywords
- Bioequivalence Amoxicillin Clavulanic acid 600mg 42.9 mg per 5 mL oral suspension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Oct 2008 (estimated)
- 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.
The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, under fasting conditions.
Detailed description
This was a single center, randomized, single-dose, open-label, 2 - way crossover bioequivalence study to compare the rate and extent of absorption of a test amoxicillin - clavulanic acid versus Augmentin ES - 600, a reference amoxicillin - clavulanic acid, under fasting condition. Prior to study commencement, subjects were randomly assigned to a treatment in accordance with the randomization scheme generated by Anapharm. Subjects were confined to the Anapharm Clinical Research Facility from at least 10 hours prior to the drug administration until after the 12 - hour post dose blood draw, in each period. The treatment phases were separated by a washout period of 20 days.
A total of 55 healthy, adult subjects signed the study - specific Informed Consent Form and were confined for Period I; of these subjects, 48 (24 males and 24 females) were enrolled and were dosed in the study; 42 of these enrolled subjects completed the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionAmoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension of ranbaxy |
| 2 | Active comparator | Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionAugmentin ES - 600 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, SFBC Anapharm Web site, SFBC Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:
Key exclusion criteria (24 listed)
- Subjects to whom any of the following applies will be excluded from the study:
- 50 mL to 599 mL of whole blood within 30 days
- More than 499 ml of whole blood within 56 days prior to the drug administration t) Wear of dentures or presence of braces at the time of dosing or any piercing in mouth, lips, and/ or tongue u) Positive urine pregnancy test at screening v) Breast feeding subject w) Female subjects of child bearing potential having unprotected sexual intercourse with any non - sterile male partner (i.e. male who have not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Hormonal contraceptives are permitted during the study but are not an acceptable method of contraception. Acceptable methods of contraception are:
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration)
- Condom or diaphragm + spermicide
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 acid 600mg - 42.9 mg/ 5 mL oral suspension | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 23 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension in people with Healthy, run by Ranbaxy Laboratories Limited 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 4 inclusion and 24 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 23 Oct 2008. 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.
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?
Bioequivalence. 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 23 Oct 2008.