Avandamet Bioequivalence Study Brazil - Fed Administration

• Status: Completed
• Trial end date: 2009-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Maleic acid; Metformin; Rosiglitazone

Criteria

EXCLUSION CRITERIA:

• The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;

• History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;

• History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;

• Hypo or hypertension of any etiologic that needs pharmacologic treatment;

• The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;

• Has history of alcohol or drugs abuse;

• History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;

• Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,

• Pregnancy or breastfeeding,

• Smoking;

• Use of regular medication within 4 weeks prior to study iniciation;

• Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.

INCLUSION CRITERIA:

• Age between 18 and 50 years;

• Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);

• Good health conditions;

• Obtain the Informed Consent's signed.