Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

NCT01089179 | Completed Phase 1

• 1 other identifier: PK-07- 017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.

Conditions

Type 2 Diabetes

Study Arms (2)

Torrent's Metformin tablets 500 mg

EXPERIMENTAL

Drug: Metformin

Glucophage XR® of Bristol- Myers Squibb Company, USA)

ACTIVE COMPARATOR

Drug: Metformin

Interventions

Metformin DRUG

Glucophage XR® of Bristol- Myers Squibb Company, USA); Torrent's Metformin tablets 500 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects in the range of 18 - 45 years of age.
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
• Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
• Willingness to follow the protocol requirement as evidenced by written, informed consent.
• Agreeing to, not using any medication (prescription and over the counter), including vitamins and minerals for two weeks prior to study \& during the course of the study.
• No history or presence of significant alcoholism or drug abuse in the past one year.
• Non-smokers, ex smokers and light smokers will be included. " Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.

You may not qualify if:

• Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: selective serotonin reuptake inhibitors (SSRIs), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• Refusal to abstain from food for ten (10) hours prior to study drug administration on first day of each study period and for four (4) additional hours each, post dose.
• Refusal to abstain from water for one hour pre dose and for two (2) hours, post dosing.
• Any contraindication to blood sampling.
• Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.
• Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
• Known history of allergic reactions to Metformin or other related drugs.
• History of drug abuse in the past one year.
• Use of prescription medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 2 weeks prior to administration of study medication, except for topical products without systemic absorption.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Torrent Research Centre

Bhat, Gujarat, 382 428, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 18, 2010
• Last Updated: May 7, 2010

Record last verified: 2010-03

Locations

IN (1)