Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting 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: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
The objective of this study was to compare the relative bioavailability of Fosinopril sodium
and hydrochlorothiazide 20-12. 5 mg tablets by Ranbaxy Laboratories Limited with that of
Monopril ®.-HCT 20-12. 5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1
x 20-12. 5 mg tablet) in healthy adult subjects under fasting conditions
Clinical Details
Official title: A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/12.5 mg Tablets Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Detailed description:
This study was a single dose, randomized, two period, two treatment, two sequence crossover
study design was used to evaluate the relative bioavailability of Fosinopril sodium and
hydrochlorothiazide tablet products when dose (1 x 20-12. 5 mg) under fasting conditions. The
two periods of the study were separated by a washout period of at least a week.
A total of 36 healthy adult subjects were enrolled in the study. Of all the subjects 34
subjects (21 males and 13 females) completed the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects should be at least 18 years old
2. Female subjects with negative serum pregnancy test
3. Subject with no clinically significant abnormal lab values at the pre-entry
evaluation
4. Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C
and HIV screening
5. Subject has acceptable ECG
6. Subject has no evidence of underlying disease at the pre-entry physical examination
7. Subject has agreed to undergo at least a 14 day washout period for prescription drugs
prior to the first dosing of the study and throughout the periods of blood sample
collection
8. Subject has agreed to undergo at least a 7 day washout period for OTC products,
herbal medications, etc. prior to the first dosing of the study medication and
throughout the periods of blood sample collections
9. Subject agrees to abstain from consuming alcohol for at least 48 hours prior to each
dosing and throughout the periods when blood samples are being obtained
10. Subject agrees to abstain from consuming grapefruit, grapefruit juice, or other foods
containing grapefruit for at least 48 hours prior to each dosing and throughout the
periods when blood samples are being obtained
11. Subject has given a written consent to participate
Exclusion Criteria:
1. Subject has a history of chronic alcohol consumption (during past 2 years) or drug
addiction
2. Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular
disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or
glaucoma
3. Subject has a history of allergic responses to the class of drug being tested.
4. Subject has donated any blood and/ or plasma within the last thirty (30) days prior
to the first dosing of the study
5. Subject has taken any investigational drug within thirty (30) days prior to the first
dosing of the study
6. Female subjects who are pregnant, breast feeding, or likely to be come pregnant
during the study. 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 the last blood collection)
7. Female 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 the study dosing, or
used oral hormonal contraceptives within 14 days before dosing.
8. Subject with the inability to read and/ or sign the consent form
Locations and Contacts
Gateway Medical Research Inc, St Charles, Missouri 63301, United States
Additional Information
Starting date: March 2003
Last updated: October 22, 2008
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