Clinical trial NCT01164761: Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Crossover
Ramipril
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 fasting conditions.

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.

Primary outcomes:
measure: Bioavailability based on Cmax and AUC parameters
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutic Research Limited
state: Gujrat
Study officials:
affiliation: Lambda Therapeutic Research Limited
name: Mr. Charu Gautam, MD, DNB
role: PRINCIPAL_INVESTIGATOR
References: