Status:
COMPLETED
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting conditions.
Detailed Description
This was a blinded, randomized, single dose, 3-way crossover comparative bioavailability study performed on 27 healthy adult volunteers (13 males and 14 females). In each period, subjects were housed ...
Eligibility Criteria
Inclusion
- Subject candidates fulfilled all of the following inclusion criteria to be eligible for the participation in the study, unless otherwise specified.
- Healthy adult male or female volunteers, 18 - 55 years of age;
- 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);
- Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
- Females of childbearing potential were to be either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or 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 prior to the first dose and throughout the study;
- Surgical sterilization of the partner (vasectomy for 6 months minimum);
- Hormonal contraceptives for at least 3 months prior to the first dose of the study
- Other birth control methods may have been deemed acceptable e) Postmenopausal women with amenorrhea for at least 2 years were eligible f) Voluntarily consented to participate in the study
Exclusion
- Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of :
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin;
- Female subjects who were pregnant or lactating. c) Positive results on HIV, HbsAg and/ or HCV tests. d) Subjects who were on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study e) Subjects who through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days, or
- 1500 mL of blood in 180 days, or
- 2500 mL of blood in 1 year. f) Subjects who participated in another clinical trial within 28 days prior to the first dose
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00778778
Start Date
May 1 2005
End Date
August 1 2005
Last Update
October 23 2008
Active Locations (1)
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1
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R2N6