Avandamet Bioequivalence Study Brazil - Fed Administration
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ClinicalTrials.gov Identifier: NCT01332071 |
Recruitment Status
:
Completed
First Posted
: April 8, 2011
Results First Posted
: April 8, 2011
Last Update Posted
: July 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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. |
Actual Study Start Date : | November 24, 2009 |
Actual Primary Completion Date : | December 6, 2009 |
Actual Study Completion Date : | December 6, 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- 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) ]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) ]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) ]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) ]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) ]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) ]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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332071
Brazil | |
GSK Investigational Site | |
Goiania, Goiás, Brazil |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01332071 History of Changes |
Other Study ID Numbers: |
114040 |
First Posted: | April 8, 2011 Key Record Dates |
Results First Posted: | April 8, 2011 |
Last Update Posted: | July 12, 2017 |
Last Verified: | June 2017 |
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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |