Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions
NCT ID: NCT00777972
Last Updated: 2008-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2003-03-31
2003-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited
Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
2
Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12.5 mg tablet
Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
Interventions
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Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Laboratories
Locations
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Gateway Medical Research Inc
Saint Charles, Missouri, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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B035501
Identifier Type: -
Identifier Source: org_study_id