Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions

NCT00879788 | Completed DMC

• 1 other identifier: 135_RAMIP_06
• Study Type: interventional
• Target: 32
• 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 10 mg capsules of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol in healthy, adult, male, human subjects under fed condition.

Conditions

Healthy

Keywords

Ramipril fed condition

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fed 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.
• Had a non-vegetarian diet habit.

You may not qualify if:

• Hypersensitivity, allergy to ramipril or related group of drugs.
• History of anaphylaxis/anaphylactoid reactions.
• History of fever in the week preceding the study.
• History of seizures and sleep disorders.
• History of chronic cough, bronchial asthma.
• 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 mmHg at predose.
• History of frequent syncopal attacks, frequent palpitations.
• History of angina, myocardial infarction or angioedema.
• History of severe diarrhea or vomiting in the week preceding the study.
• History of dry cough.
• History of congestive heart failure.
• 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 were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)

New Delhi, 110 062, 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: October 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: April 10, 2009

Record last verified: 2009-04

Locations

IN (1)