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

A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Metformin Hydrochloride 1000 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics, India) to be Compared With Glucophage® (Metformin Hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb, USA) in 48 + (2 Standby) Healthy, Adult, Human Subjects Under Fed Conditions

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 48 + (2 standby) healthy, adult, human subjects under fed conditions.

To monitor adverse events and to ensure the safety of subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Metformin; Drug: Glucophage

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 fed conditions.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra pradesh
    • Hyderabad, Andhra pradesh, India, 500051
      • Vimta Labs Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Metformin; Metformin Hydrochloride 1000 mg tablets of Dr. Reddy's Laboratories Limited	Drug: Metformin; Metformin Tablets 1000 mg; Other Names: Glucophage Tablets 1000 mg
ACTIVE_COMPARATOR: Glucophage; Glucophage 1000 mg tablets of Bristol-Myers Squibb	Drug: Glucophage; Glucophage 1000 mg tablets of Bristol-Myers Squibb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence on Cmax, AUC, Tmax,t1/2 parameters	4 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (ACTUAL): May 1, 2005
• Study Completion (ACTUAL): May 1, 2005

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (ESTIMATE): July 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 13, 2010
• Last Update Submitted That Met QC Criteria: July 12, 2010
• Last Verified: January 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 8322