Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

Biocinese

Status: Unknown

Conditions: Nutritional and Metabolic Diseases

Treatments: Drug: Metformin; Drug: Glifage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367054

06/2008

Met 2005 (Other Identifier)

Details and patient eligibility

About

The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

Full description

OBJECTIVE: To evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

MATERIAL AND METHODS: The study was approved by research Ethics Committee and all twenty-eight volunteers signed the selected IC. An open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. Twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. Plasma samples were analyzed by liquid chromatography mass spectrometry (LC-MS/MS). Statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (Cmax) and area under the curve (AUC 0-te AUC 0-inf). Analysis of variance (ANOVA) model appropriate was employed for the two periods cross under the logarithmically transformed data.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Within 10% of their ideal body weight
• Age between 18 and 50 years
• Healthy conditions
• Ability to understand the written informed consent

Exclusion criteria

• Pregnancy
• Smokers
• Alcohol and drugs

Trial design

26 participants in 1 patient group

Metformin

Experimental group

Description:

500 mg

Treatment:

Drug: Glifage

Drug: Metformin