Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions

NCT00879476 | Completed DMC

• 1 other identifier: 245_RAMIP_06
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under fasting condition.

Conditions

Healthy

Keywords

Bioequivalence ramipril fasting condition

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fasting conditions

Study Arms (2)

1

EXPERIMENTAL

Ramipril capsules 10 mg (containing Ramipril 10 mg)of of OHM Laboratories Inc., USA (a subsidiary of Ranbaxy Pharmaceuticals Inc), USA

Drug: Ramipril 10mg capsules

2

ACTIVE COMPARATOR

ALTACE® capsule 10 mg (containing Ramipril 10 mg)of King Pharmaceuticals Inc., Bristol, TN 37620, USA

Drug: Ramipril 10mg capsules

Interventions

Ramipril 10mg capsules DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, 201 301, India

Location

Related Links

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MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

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: April 9, 2009
• First Posted: April 10, 2009
• Study Start: January 1, 2007
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: April 10, 2009

Record last verified: 2009-04

Locations

IN (1)