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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00777972
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention
Healthy
Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/12.5 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 2003
Study Completion Date: April 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited
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
Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777972

Locations
United States, Missouri
Gateway Medical Research Inc
St Charles, Missouri, United States, 63301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00777972     History of Changes
Other Study ID Numbers: B035501
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets fasting conditions

Additional relevant MeSH terms:
Fosinopril
Hydrochlorothiazide
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014