Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00872235
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.) in healthy, adult, human, male, subjects under fed conditions.


Condition Intervention
Healthy
Drug: fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label, Balanced, Randomised, Two-Treatment, Four-Period, Two-Sequence, Single-Dose, Crossover, Fully Replicated Bioavailability Study on Fixed-Dose Combination of Quinapril 20 mg and Hydrochlorothiazide 25 mg Tablets of OHM Laboratories Inc.(Division of Ranbaxy Laboratories Limited) With Accuretic 20-25 mg Tablets (Fixed Dose Combination of Quinapril 20 mg and Hydrochlorothiazide 25 mg) of Parke-Davis (Division of Pfizer Inc.) in Healthy, Adult, Human, Male Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence evaluation of Quinapril hydrochloride 20 mg and Hydrochlorothiazide 25 mg tablets under fed conditions [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2005
Study Completion Date: November 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc.(division of Ranbaxy Laboratories Limited)
Drug: fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Active Comparator: 2
Accuretic tablets (fixed dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg)
Drug: fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Experimental: 3
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc.(division of Ranbaxy Laboratories Limited)
Drug: fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Active Comparator: 4
Accuretic tablets (fixed dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg)
Drug: fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets

Detailed Description:

The subjects received a single oral dose of either Test or Reference product, containing fixed-dose combination of Quinapril 20 mg and Hydrochlorothiazide 25 mg after an overnight fast of at least 10 hours. The study drug was administered as per the SAS generated Randomization Code, 30 minutes after serving of a high-fat high-calorie breakfast under supervision of a trained Medical Officer in each period.Blood samples were collected predose and at intervals over 72 hours after each dose. A 7-day interval was maintained between each dosing in the Study Periods I-IV.

During the course of the study safety parameters assessed were vital signs, physical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated and sodium & potassium levels were estimated at the 24 hours post dose of the last period of the study.

A total of 40 subjects were randomized to receive fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets and 37 subjects completed all the four periods of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be in the age range of 18-45 years.
  2. Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Have voluntarily given written informed consent to participate in this study.
  4. Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study.

Exclusion Criteria:

  1. History of allergy to quinapril, hydrochlorothiazide, sulfonamide derived drugs or related ACE inhibitors.
  2. History of anuria, gout or dry cough.
  3. History of diarrhea or vomiting in the last one week.
  4. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  5. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  6. Presence of values, which are significantly different from normal, reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  7. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
  8. Presence of values, which are significantly different from normal, reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  9. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
  10. Clinically abnormal ECG or Chest X-ray.
  11. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma or angioedema due to any cause.
  12. History of any psychiatric illness which may impair the ability to provide written informed consent.
  13. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  14. History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
  15. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  16. Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  17. A haemoglobin concentration of less than 7 % of lower limit of reference range e.g. 13 gm % for reference range of 14-18 gm at screening.
  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: NCT00872235

Locations
India
Ranbaxy CPU
New Delhi, India, 110 062
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00872235     History of Changes
Other Study ID Numbers: CPU-M-024/QUINH-45/05
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Ranbaxy Inc.:
Bioequivalence fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets

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

ClinicalTrials.gov processed this record on July 23, 2014