Avandamet Bioequivalence Study Brazil - Fed Administration

Phase 1

Completed

Conditions: Diabetes Mellitus, Type 2

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

Registration Number: NCT01332071

Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Avandamet test product	Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg	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
Avandamet reference product	Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg	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

Primary Outcome Measures

Name	Time	Method
AUC0-t of Rosiglitazone Maleate	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
Cmax of Rosiglitazone Maleate	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
AUC0-infinity of Rosiglitazone Maleate	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
AUC0-t of Metformin Hydrochloride	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
AUC0-infinity of Metformin Hydrochloride	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
Cmax of Metformin Hydrochloride	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.