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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01164761
First received: July 16, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 fasting conditions and to assess the bioequivalence.
  • To monitor the safety of the subjects.

Condition Intervention Phase
Healthy
Drug: Ramipril
Drug: Altace
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2005
Study Completion Date: October 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramipril
Ramipril 10 mg capsules of Dr. Reddy's Laboratories Limited
Drug: Ramipril
Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
Other Name: Altace@10 mg Capsules
Active Comparator: Altace
Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
Drug: Altace
Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

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 fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164761

Locations
India
Lambda Therapeutic Research Limited
Ahmedabad, Gujrat, India, 380054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mr. Charu Gautam, MD, DNB Lambda Therapeutic Research Limited
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan / Senior Manager R & D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01164761     History of Changes
Other Study ID Numbers: 074-05
Study First Received: July 16, 2010
Last Updated: July 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Crossover
Ramipril

Additional relevant MeSH terms:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014