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

NCT00872235 | Completed DMC

• 1 other identifier: CPU-M-024/QUINH-45/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of Quinapril hydrochloride 20 mg and Hydrochlorothiazide 25 mg tablets under fed conditions

Study Arms (4)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

3

EXPERIMENTAL

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

4

ACTIVE COMPARATOR

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

Interventions

fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets DRUG

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be in the age range of 18-45 years.
• Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Have voluntarily given written informed consent to participate in this study.
• 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.

You may not qualify if:

• History of allergy to quinapril, hydrochlorothiazide, sulfonamide derived drugs or related ACE inhibitors.
• History of anuria, gout or dry cough.
• History of diarrhea or vomiting in the last one week.
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• 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.
• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
• 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.
• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
• Clinically abnormal ECG or Chest X-ray.
• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma or angioedema due to any cause.
• History of any psychiatric illness which may impair the ability to provide written informed consent.
• Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
• 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.
• Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy CPU

New Delhi, New Delhi, 110 062, India

Location

Related Links

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MeSH Terms

Interventions

Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: June 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: November 1, 2005
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

IN (1)