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

NCT ID: NCT01160042

Last Updated: 2010-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-04-30

Brief 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.

Detailed Description

Open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,crossover bioequivalence study with at least 07 days of washout period between each drug administration under fasting conditions.

Conditions

Healthy

Study Design

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

Study Groups

Metformin

Metformin Hydrochloride 1000 mg tablets of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin Tablets 1000 mg

Glucophage

Glucophage 1000 mg tablets of Bristol-Myers Squibb

Group Type: ACTIVE_COMPARATOR

Glucophage

Intervention Type: DRUG

Glucophage 1000 mg tablets of Bristol-Myers Squibb

Interventions

Metformin

Metformin Tablets 1000 mg

Intervention Type: DRUG

Glucophage

Glucophage 1000 mg tablets of Bristol-Myers Squibb

Intervention Type: DRUG

Other Intervention Names

Glucophage Tablets 1000 mg

Eligibility 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.

• 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

Mangesh Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Vimta Labs Ltd.

Locations

Vimta Labs Ltd.

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

8313

Identifier Type: -

Identifier Source: org_study_id