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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01164774
• Date of registration: 16/07/2010
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions
• Scientific title: 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
• Date of first enrolment: October 2005
• Target sample size: 54
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01164774
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Mr. Charu Gautam, MD, DNB
• Affiliation: Lambda Therapeutic Research Limited

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Altace

Drug: Ramipril

Primary Outcome(s)

Bioavailability based on Cmax and AUC parameters [Time Frame: 2 months]

Secondary ID(s)

075-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors