Avandamet Bioequivalence Study Brazil - Fed Administration

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332071
• Other study ID #: 114040
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2010
• Last updated: April 14, 2011
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Institutional Review BoardBrazil: ANVISA
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy Volunteers

Intervention

Drug:
• Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg
Avandamet reference product
• Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Avandamet test product

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Goiania	Goiás

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	Yes
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	Yes
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	Yes
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	No
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	No
Primary	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.	Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)	No