Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions

NCT01164774 | Completed Phase 1 DMC

• 1 other identifier: 075-05
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

• To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting conditions and to assess the bioequivalence.
• To monitor the safety of the subjects.

Conditions

Healthy

Keywords

Bioavailability; Crossover; Ramipril

Outcome Measures

Primary Outcomes (1)

• Bioavailability based on Cmax and AUC parameters

  2 months

Study Arms (2)

Ramipril

EXPERIMENTAL

Ramipril 10 mg capsules of Dr. Reddy's Laboratories Limited

Drug: Ramipril

Altace

ACTIVE COMPARATOR

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Drug: Altace

Interventions

Ramipril DRUG

Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited

Also known as: Altace@10 mg Capsules

Ramipril

Altace DRUG

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Altace

Eligibility Criteria

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

You may qualify if:

• Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
• Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2
• Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
• Able to comply with the study procedures, in the opinion of the investigator.
• Able to give written consent for participation in the trial.

You may not qualify if:

• Known hypersensitivity or idiosyncratic reaction to ramipril or any other related drugs.
• Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
• Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert
• Any history or presence of asthma (including aspirin induced asthma)or nasal polyp.
• A recent history of alcoholism \< 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
• Smokers, who smoke more than 10 cigarettes/day or inability to abstain from smoking during the study.
• The presence of clinically significant abnormal laboratory values during screening.
• Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
• History of psychiatric disorders.
• A history of difficulty in donating blood.
• Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
• Note: In case, the blood loss was ≤ 200 mL, subject may be enrolled 60 days after the blood donation.
• A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti-HAV antibodies.
• A positive test result for HIV antibody and/or syphilis.
• Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject can be dosed after completion of 60 days after the last sample of the previous study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Limited

Ahmedabad, Gujarat, 380054, India

Location

MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mr. Charu Gautam, MD, DNB

  Lambda Therapeutic Research Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: October 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: November 1, 2005
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

IN (1)