Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fed Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
The objective of this study was to compare the single-dose relative bioavailability of
Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg
clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet
dose under fed conditions
Clinical Details
Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg Amoxicillin (as the Trihydrate)/57 mg Clavulanic Acid (as the Potassium Salt) Chewable Tablets in Healthy Adult Volunteers Following Administration of a Two Tablet Dose Under Fed Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Detailed description:
The study was conducted as an open-label, randomized, 2-way crossover study to compare the
single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin® 40o mg)
amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable
tablet, following administration of 2 tablet dose under fed conditions A total of 40
Subjects, 20 males and 20 females; were enrolled in the study, and 39 subjects, 20 males and
19 females, completed the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy adult male or female volunteers, 18-55 years of age
2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal
weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company,
1983);
3. Medically healthy subjects with clinically normal laboratory profiles;
4. Females of childbearing potential should either be sexually inactive (abstinent) for
14 days prior to the study and throughout the study or be using one of the
following acceptable birth control methods:
surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6
months minimum; IUD in place for at least 3 months; barrier methods (condom,
diaphragm) with spermicide for at least 14 days pror to the start of the study and
.throughout the study; surgical sterilization of the partner (vasectomy for 6 months
minimum); hormonal contraceptives for at least 3 months pdor to the start of the
study. Other birth control methods may be deemed acceptable. Postmenopausal women
with amenorrhea for at least 2 years will be eligible;
5. Voluntarily consent to participate in the study.
Exclusion Criteria:
Subject candidates must not be enrolled in the study if they meet any of the following
criteria:
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or
psychiatric disease.
2. In addition, history or presence of:
alcoholism or drug abuse within the past 2 years; hypersensitivity or idiosyncratic
reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin
and/or clavulanic acid
3. Female subjects who are pregnant or lactating.
4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days
prior to the first dose.
5. Subjects who have made a donation (standard donation amount or more) of blood or
blood products (with the exception of plasma as noted below) within 30 days prior to
the study.
6. Subjects who have made a plasma donation within 7 days prior to the study
7. Subjects who have participated in another clinical trial within 30 days prior to the
first dose.
Locations and Contacts
MDS Pharma Services, Phoenix, Arizona 85044, United States
Additional Information
Starting date: October 2002
Last updated: October 22, 2008
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