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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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 One subject (subject number 18) dropped out of the study and two subjects (subject number 47 and 50) were withdrawn from the study.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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Noida,, Uttar Pradesh, India, 201 301
      • Ranbaxy Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence evaluation of Ranbaxy Quinapril hydrochloride 20 mg and Hydrochlorothiazide 25 mg tablets under fasting conditions

Collaborators and Investigators

• Sponsor: Ranbaxy Laboratories Limited

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2009
• Last Update Submitted That Met QC Criteria: March 30, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Quinapril
• Other Study ID Numbers: 255_QUIHY_07