Status:
COMPLETED
Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-...
Detailed Description
This study was a single dose, randomized, two-period, two-sequence, crossover design study. It was used to evaluate the relative bioavailability of the Fosinopril sodium and hydrochlorothiazide tablet...
Eligibility Criteria
Inclusion
- Subjects should be at least 18 years old
- Female subjects with negative serum pregnancy test
- Subject with no clinically significant abnormal lab values at the pre-entry evaluation
- Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C and HIV screening
- Subject has acceptable ECG
- Subject has no evidence of underlying disease at the pre-entry physical examination
- 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
- 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
- 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
- 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
- Subject has given a written consent to participate
Exclusion
- Subject has a history of chronic alcohol consumption (during past 2 years) or drug addiction
- Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
- Subject has a history of allergic responses to the class of drug being tests
- Subject has donated any blood and/ or plasma within the last thirty (30) days prior to the first dosing of the study
- Subject has taken any investigational drug within thirty (30) days prior to the first dosing of the study
- 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)
- 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.
- Subject with the inability to read and/ or sign the consent form
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00778713
Start Date
March 1 2003
End Date
April 1 2003
Last Update
October 23 2008
Active Locations (1)
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1
Gateway Medical Research Inc
Saint Charles, Missouri, United States, 63301