- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00778778
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
Blinded, Comparative, Randomized, Single-Dose, Three Way Crossover Bioavailability Study of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg Cefprozil Tablets in Healthy Adult Volunteers Under Fasting Conditions.
Study Overview
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 from at least 10 hours before dosing until after the 10 hour post dose events. Subjects received a single oral 500 mg cefprozil dose of their assigned formulation, with 240 mL of water under fasting condition. Food was restricted from 10 hours before dosing until 4 hours post dose and water was not permitted from 2 hours before dosing and was restricted until 2 hours following dosing but was allowed ad libitum at all other times. The doses were separated by a washout period of 14 days.
A total of twenty seven (27) healthy adult volunteers (13 males and 14 females) were enrolled in the study, out of which only twenty four (24) subjects (11 males and 13 females) completed the clinical phase of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Saint-Laurent, Montreal, Quebec, Canada, H4R2N6
- MDS Pharma Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Cefprozil 500mg tablets of ranbaxy
|
|
ACTIVE_COMPARATOR: 2
CEFZIL ® 500 mg cefprozil tablets of BMS, USA
|
|
ACTIVE_COMPARATOR: 3
CEFZIL ® 500 mg tablets, BMS Canada
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequivalence
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA27168
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on cefprozil 500mg tablets
-
Ranbaxy Laboratories LimitedCompleted
-
SandozCompleted
-
Teva Pharmaceuticals USACompleted
-
PfizerPfizerRecruitingSickle Cell DiseaseUnited States
-
The Affiliated Hospital of Qingdao UniversityCompleted
-
Joint Stock Company "Farmak"Completed
-
Teva Pharmaceuticals USACompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedPolycystic Ovary SyndromeNorway