Status:
COMPLETED
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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 hydrochlor...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00872235
Start Date
June 1 2005
End Date
November 1 2005
Last Update
March 31 2009
Active Locations (1)
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1
Ranbaxy CPU
New Delhi, New Delhi, India, 110 062