Clinical trial NCT01332071: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin
Rosiglitazone
Healthy volunteers
Avandamet
Fed conditions
Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: AUC0-t of Rosiglitazone Maleate
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
measure: Cmax of Rosiglitazone Maleate
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
measure: AUC0-infinity of Rosiglitazone Maleate
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
measure: AUC0-t of Metformin Hydrochloride
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
measure: AUC0-infinity of Metformin Hydrochloride
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
measure: Cmax of Metformin Hydrochloride
timeFrame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: GSK Investigational Site
state: Goiás
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: