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

NCT01367054 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2011-06-06

No results posted yet for this study

Summary

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.

Conditions

  • Nutritional and Metabolic Diseases

Interventions

DRUG

Metformin

500 mg tablet

DRUG

Glifage

500 mg tablet

Sponsors & Collaborators

  • Biocinese

    lead INDUSTRY

Principal Investigators

  • Josélia Manfio, Dr · Biocinese

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367054 on ClinicalTrials.gov