Overview

Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Treatments:
Fosinopril
Criteria
Inclusion Criteria:

- Non-institutionalized subjects consisting of members of the community at large.

Characterization of Study Group

- All subjects selected for this study will be at least 18 years of age.

- Clinical laboratory measurements will include the following:

Hematology:

- hemoglobin, hematocrit,

- red blood cell count,

- platelets, and white blood cell count (with differential).

Clinical Chemistry:

- creatinine, BUN, glucose, SGOT/AST,

- SGPT/ALT, bilimbin, and alkaline phosphatase.

Urine Analysis:

- pH, specific gravity,

- protein, glucose, ketones,

- bilimbin, occult blood, and cells.

HIV Screen:

- (pre-study only) Hepatitis-B, C Screen:

- (pre-study only) Drugs of Abuse Screen:

- pre-study and at check-in each study period

Exclusion Criteria:

- Subjects with a history of chronic alcohol consumption (during past 2 years), drug
addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,
tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma
will not be eligible for this study.

- Subjects whose clinical laboratory test values are greater than 20% outside the normal
range may be retested. If the clinical values are outside the range on retesting, the
subject will not be eligible to participate in the study unless the clinical
investigator deems the result to not be significant.

- Subjects who have a history of allergic responses to the class of drug being tested
(including any penicillin product) should be excluded from the study.

- All subjects will have urine samples assayed for the presence of drugs of abuse as
part of the clinical laboratory screening procedures and at check-in each study
period. Subjects found to have urine concentrations of any of the tested drugs will
not be allowed to participate.

- Subjects should not have donated blood and/or plasma for at least thirty (30) days
prior to the first dosing of the study.

- Subjects who have taken any investigational drag within thirty (30) days prior to the
first dosing of the study will not be allowed to participate.

- Female subjects who are pregnant or who are able (women with child bearing potential)
to become pregnant during the study will not be allowed to participate. Female
subjects of child bearing potential must either abstain from sexual intercourse or use
a reliable barrier method (eg condom, IUD) of contraception during the course of the
study (first dosing until last blood collection) or they will not be allowed to
participate. Subjects who have used implanted or injected hormonal contraceptives
(except Lunelle monthly injection) anytime during the 6 months prior to study dosing,
Lunelle monthly injection anytime during the 45-days prior to study dosing or used
hormonal contraceptives within 14 days before dosing will not be allowed to
participate.

- All female subjects will be screened for pregnancy at check in in each study period.
Subjects with positive or inconclusive results will be withdrawn from the study.