Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition

NCT01089166 | Completed Phase 1

• 1 other identifier: PK-07- 016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting 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:

• Subjects must meet all of the following criteria in order to be included in the study:
• Sex: male.
• Age: 18 - 45 years.
• Subject with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
• Healthy and willing to participate in the study.
• Subject willing to adhere to the protocol requirements and to provide written informed consent.
• Non-smokers or smoker who smokes less than 10 cigarettes a day.

You may not qualify if:

• The subjects will be excluded from the study based on the following criteria:
• Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• Clinically significant abnormal ECG or Chest X-ray.
• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50/minute or more than 100/minute.
• Oral temperature less than 95°F or more than 98.6°F.
• Respiratory rate less than 12/minute or more than 20/minute
• Addiction to alcohol or history of any drug abuse within the past 2 years.
• Recent History of kidney or liver dysfunction.
• History of allergy to the test drug or any drug chemically similar to the drug under investigation.
• Administration/ Intake of prescription or OTC medication for two weeks before the study.
• Patients suffering from any chronic illness such as arthritis, asthma etc.
• HIV, HCV, HBsAg positive Subjects.
• Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive Subjects based on urine test.
• Subjects suffering from any psychiatric (acute or chronic) illness requiring medications.

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 Officials

• Jogesh mahajan, MBBS

  Torrent Pharma Ltd.

  PRINCIPAL INVESTIGATOR

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: June 22, 2010

Record last verified: 2010-03

Locations

IN (1)