Avandamet Bioequivalence Study Brazil - Fed Administration - Clinical Trial for Diabetes Mellitus, Type 2 | NCT01332071

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Metformin, Rosiglitazone, Healthy volunteers, Avandamet, Fed conditions, Bioequivalence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Avandamet test product

Avandamet reference product

Arm 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

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

Outcomes

Primary Outcome Measures

AUC0-t of Rosiglitazone Maleate

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

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

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01332071

First Posted

August 31, 2010

Last Updated

June 14, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01332071

Brief Title

Avandamet Bioequivalence Study Brazil - Fed Administration

Official Title

Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 24, 2009 (Actual)

Primary Completion Date

December 6, 2009 (Actual)

Study Completion Date

December 6, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Metformin, Rosiglitazone, Healthy volunteers, Avandamet, Fed conditions, Bioequivalence

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Avandamet test product

Arm Type

Active Comparator

Arm 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

Arm Title

Avandamet reference product

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Avandamet reference product

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Avandamet test product

Primary Outcome Measure Information:

Title

AUC0-t of Rosiglitazone Maleate

Description

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.

Time Frame