Status:
COMPLETED
Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg of OHM Laborator...
Detailed Description
Following an overnight fast of at least 10 hour, a single oral dose of ramipril 10 mg capsule was administered during each period of the study, along with 240 mL of drinking water at ambient temperatu...
Eligibility Criteria
Inclusion
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- 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
- Hypersensitivity or allergy to ramipril or related group of drugs.
- 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 at screening
- History of hypertension, hypotension, angina, myocardial infarction or angioedema.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- 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 might impair the ability to provide written informed consent.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- 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.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
- 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.
- 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.
- Regular smokers who smoked more than 10 cigarettes daily or had 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 had 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.
- Subjects who, through completion of this study, would have had donated and/or lost more than 350 mL of blood in the past month.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00879476
Start Date
January 1 2007
End Date
March 1 2007
Last Update
April 10 2009
Active Locations (1)
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1
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited
Noida, Uttar Pradesh, India, 201 301