Overview

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition

Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
Male
Summary
The objectives of this study are: To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr. Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg tablets (Bristol-Myers Squibb, USA) in 52 + (2 standby) healthy, adult, human subjects under fasting conditions. To monitor adverse events and to ensure the safety of subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Metformin
Criteria
Inclusion Criteria:

- Subjects who provided written informed consent.

- Subjects who were healthy within 18-45 years of age (inclusive) weighing at least 50
kg.

- Subjects who were within ±10% of ideal body weight in relation to height according to
Life Insurance Corporation of India height-weight chart for non-medical cases.

- Subjects with normal health as determined by medical history and physical examination
performed within 15 days prior to the commencement of the study.

- Subjects with normal ECG, X-ray and vital signs.

- Availability of subject for the entire study period and willingness to adhere to
protocol requirements as evidenced by written informed consent

- If subject is a female volunteer and

- is of child bearing potential practicing an acceptable method of birth control
for the duration of the study as judged by the investigator(s), such as condoms,
foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.

- is postmenopausal for at least 1 year.

- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the subject)

Exclusion Criteria:

- Subjects incapable of understanding the informed consent.

- Subjects with BP:≤90/60 or BP≥140/90.

- History of hypersensitivity or idiosyncratic reaction to Metformin or other
Biguanides.

- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal,
endocrine, immunologic, neurologic and haematologic function.

- Regular smoker who smokes more than ten cigarettes daily and has difficulty in
abstaining from smoking for the duration of each study period.

- Subjects who has taken over the counter or prescribed medications, including any
enzyme modifying drugs or any systemic medication within the past 30 days prior to
start of clinical period.

- History of any psychiatric illness, which may impair the ability to provide written,
informed consent.

- Subjects who have a history of alcohol or substance abuse within the last 5 years.

- Subjects with clinically significant abnormal values of laboratory parameters.

- Subjects who have participated in any other clinical investigation using experimental
drug or had bled more than 350 mL in the past 3 months.

- Subjects who tested positive at screening for HIV, HbsAg or HCV

- Subjects with positive urine drug screen test for drugs of abuse.

- Any subject in whom Metformin is contraindicated for medical reasons.

- Subjects who have used any drugs or substances such as herbal preparations known to be
strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 14
days prior to the first dose.

- Female volunteers demonstrating a positive pregnancy screen.

- Female volunteers who are currently breast-feeding.