Avandamet Bioequivalence Study Brazil - Fed Administration

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg; Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332071

114040

Details and patient eligibility

About

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.

Full description

This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets. Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets. The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years. Their body mass index (BMI) varied between 18,5 and 25. There are no restrictions regarding the ethnic group. The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.

Enrollment: 26 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Avandamet test product

Active Comparator group

Description:

Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2

Treatment:

Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg

Avandamet reference product

Active Comparator group

Description:

Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2

Treatment:

Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg