Avandamet Bioequivalence Study Brazil - Fed Administration

NCT01332071 | Completed Phase 1 Results

• 1 other identifier: 114040
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Avandamet test product

ACTIVE COMPARATOR

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 reference product

ACTIVE COMPARATOR

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

Interventions

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

Avandamet reference product

Avandamet reference product

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

Avandamet test product

Avandamet test product

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Goiânia, Goiás, Brazil

Location

Related Links

• Results for study 114040 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: April 8, 2011
• Study Start: November 24, 2009
• Primary Completion: December 6, 2009
• Study Completion: December 6, 2009
• Last Updated: July 12, 2017
• Results First Posted: April 8, 2011

Record last verified: 2017-06

Locations

BR (1)