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Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00777972
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2008
First Posted Date  ICMJE October 23, 2008
Last Update Posted Date October 23, 2008
Study Start Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2008)
Bioequivalence
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions
Official Title  ICMJE A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/12.5 mg Tablets Under Fasting Conditions
Brief 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
Study Arms  ICMJE
  • Experimental: 1
    Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited
    Intervention: Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
  • Active Comparator: 2
    Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12.5 mg tablet
    Intervention: Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2008)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777972
Other Study ID Numbers  ICMJE B035501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Tausif Monif, Ranbaxy Research Laboratories
Study Sponsor  ICMJE Ranbaxy Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ranbaxy Inc.
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP