Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
NCT ID: NCT00872235
Last Updated: 2009-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2005-06-30
2005-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc.(division of Ranbaxy Laboratories Limited)
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
2
Accuretic tablets (fixed dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg)
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
3
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc.(division of Ranbaxy Laboratories Limited)
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
4
Accuretic tablets (fixed dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg)
fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Interventions
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fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
MALE
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Labs
Locations
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Ranbaxy CPU
New Delhi, New Delhi, India
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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CPU-M-024/QUINH-45/05
Identifier Type: -
Identifier Source: org_study_id