Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of metformin hydrochloride 500 mg extended release caplet (test drug) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Male and female subjects with absence of significant diseases or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.

• Age of 18 - 55 years

• Preferably non-smokers or smoke less than 10 cigarettes per day

• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.

• BMI 18 - 25 kg/m2

• Vital signs (after 10 minutes rest) were within the following ranges:

• SBP 100 - 120 mmHg

• DBP 60 - 80 mmHg

• Pulse rate 60 - 90 bpm

Exclusion Criteria:

• Personal/family history of allergy or hypersensitivity or contraindication to metformin hydrochloride or other biguanides and allied drug.

• Pregnant or lactating women and women of childbearing potential without adequate contraception

• Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illnesses

• Clinically significant illness within 4 weeks prior to the administration of study medication

• Presence of any clinically significant abnormal values during screening

• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV

• Clinically significant haematology abnormalities

• Clinically significant electrocardiogram (ECG) abnormalities

• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug

• History of drug (cocaine, amphetamines, opiates, cannabis) or alcohol abuse within 12 months prior to screening for this study

• Participation in any clinical trial within the past 90 days

• History of any bleeding or coagulative disorders

• History or presence of asthma bronchial or related bronchospastic conditions

• History of seizures, epilepsy or any kind of neurological disorders

• History of difficulty with donating blood or difficulty in vein puncture of left or right arm

• A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day

• Intake of any prescription or non-prescription drugs, food supplements or herbal medicines within 14 days of this study's first dosing day

• Any food allergy, intolerance, restriction or special diet that in the opinion of the Research Physician, could contraindicate the subject's participation in this study

• Any reason in the opinion of the Research Physician, would prevent the subject from participating in the study