Avandamet Bioequivalence Study Brazil - Fed Administration

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332071
First received: August 31, 2010
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Diabetes Mellitus, Type 2
Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg
Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC0-t of Rosiglitazone Maleate [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Avandamet test product
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
Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Avandamet test product
Active Comparator: Avandamet reference product
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
Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg
Avandamet reference product

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332071

Locations
Brazil
GSK Investigational Site
Goiania, Goiás, Brazil
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332071     History of Changes
Other Study ID Numbers: 114040
Study First Received: August 31, 2010
Results First Received: March 17, 2011
Last Updated: April 14, 2011
Health Authority: Brazil: Institutional Review Board
Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
Metformin
Rosiglitazone
Healthy volunteers
Avandamet
Fed conditions
Bioequivalence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Maleic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014