Clinical trial NCT00840099: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility criteria: Inclusion Criteria:

* 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).
  * 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).

Exclusion Criteria:

* 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.
  * 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.

Primary outcomes:
measure: Bioequivalence Based on Cmax for Amoxicillin
timeFrame: Blood samples collected over 14 hour period
measure: Bioequivalence Based on AUC0-inf for Amoxicillin
timeFrame: Blood samples collected over 14 hour period
measure: Bioequivalence Based on AUC0-t for Amoxicillin
timeFrame: Blood samples collected over 14 hour period
measure: Bioequivalence Based on Cmax for Clavulanic Acid
timeFrame: Blood samples collected over 14 hour period
measure: Bioequivalence Based on AUC0-inf for Clavulanic Acid
timeFrame: Blood samples collected over 14 hour period
measure: Bioequivalence Based on AUC0-t for Clavulanic Acid
timeFrame: Blood samples collected over 14 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Pharma Medica Research Inc.
state: Ontario
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: