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

NCT ID: NCT01164774

Last Updated: 2010-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2005-11-30

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.

Detailed Description

A Two-way open label crossover experimental evaluation of relative bioavailabilities of Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King Pharmaceuticals in healthy adult human male subjects under non-fasting conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ramipril

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

Group Type: EXPERIMENTAL

Ramipril

Intervention Type: DRUG

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

Altace

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Group Type: ACTIVE_COMPARATOR

Altace

Intervention Type: DRUG

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Interventions

Ramipril

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

Intervention Type: DRUG

Altace

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Intervention Type: DRUG

Other Intervention Names

Altace@10 mg Capsules

Eligibility Criteria

Inclusion Criteria

1. Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.

2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2

3. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.

4. Able to comply with the study procedures, in the opinion of the investigator.

5. Able to give written consent for participation in the trial.

Exclusion Criteria

1. Known hypersensitivity or idiosyncratic reaction to ramipril or any other related drugs.

2. Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.

3. 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

4. Any history or presence of asthma (including aspirin induced asthma)or nasal polyp.

5. 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.

6. Smokers, who smoke more than 10 cigarettes/day or inability to abstain from smoking during the study.

7. The presence of clinically significant abnormal laboratory values during screening.

8. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.

9. History of psychiatric disorders.

10. A history of difficulty in donating blood.

11. 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.

12. A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti-HAV antibodies.

13. A positive test result for HIV antibody and/or syphilis.

14. The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of IP (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study).

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.

15. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IP and throughout the subjects' participation in the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert.

16. Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Mr. Charu Gautam, MD, DNB

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutic Research Limited

Locations

Lambda Therapeutic Research Limited

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

075-05

Identifier Type: -

Identifier Source: org_study_id