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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00872781
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

The study was conducted as a open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis, Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting condition.


Condition Intervention
Healthy
Drug: fixed dose combination of Quinapril HCl 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, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study Comparing Fixed Dose Combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg Tablets of OHM Laboratories Inc (a Subsidiary of Ranbaxy Pharmaceuticals Inc) With ACCURETICTM Tablets (Containing Fixed Dose Combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg) of Parke Davis, in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

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

Enrollment: 64
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc (a subsidiary of Ranbaxy pharmaceuticals Inc)
Drug: fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets
Active Comparator: 2
ACCURETICTM tablets (containing fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg)
Drug: fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets

Detailed Description:

Following an overnight fast of at least 10 hour, a single oral dose of Quinapril hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg or AccureticTM tablet 20 mg/ 25 mg (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) was administered during each period of the study, along with 240 mL of drinking water at ambient temperature and under low light condition and supervision of a trained study personnel.

A total of sixty-four (64) subjects were enrolled in the study. One subject (subject number 18) dropped out of the study and two subjects (subject number 47 and 50) were withdrawn from the study. Hence Sixty-one (61) subjects completed both the periods of the study.

For Quinapril and Hydrochlorothiazide pharmacokinetic and statistical analyses were performed on data from 61 subjects who completed both the 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. Were in the age range of 18-45 years.
  2. Were neither overweight nor underweight for their corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Had voluntarily given written informed consent to participate in this study.
  4. Were of normal health as determined by medical history and physical examination of the subjects performed within 21 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. Subject who had sitting systolic blood pressure of less than 90 mmHg or >140 mmHg and diastolic blood pressure of less than 60 mmHg or > 90 mm Hg on the day of admission.
  3. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  4. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  5. Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  6. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  7. Presence of values which were significantly different from normal reference ranges 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.
  8. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).
  9. Clinically abnormal ECG or Chest X-ray.
  10. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  11. History of any psychiatric illness which might impair the ability to provide written informed consent.
  12. Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
  13. 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 had difficulty in abstaining for the duration of each study period.
  14. Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  15. Participated in any clinical trial within 12 weeks preceding Day 1 of this study.
  16. Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.
  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: NCT00872781

Locations
India
Ranbaxy Clinical Pharmacology Unit
Noida,, Uttar Pradesh, India, 201 301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00872781     History of Changes
Other Study ID Numbers: 255_QUIHY_07
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 HCl 20 mg and Hydrochlorothiazide 25 mg tablets

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

ClinicalTrials.gov processed this record on September 16, 2014