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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg | Drug | Avandamet reference product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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EXCLUSION CRITERIA:
INCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Goiânia | Goiás | Brazil |
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| Label | URL |
|---|---|
| Results for study 114040 can be found on the GSK Clinical Study Register. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product in Period 1; Reference Product in Period 2 | Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2 |
| FG001 | Reference Product in Period 1; Test Product in Period 2 | Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| 7-Day Washout Period |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Both Test and Reference Product | Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng per hour per ml (ng.h/ml) | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product in Period 1; Reference Product in Period 2 | Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cephalea | General disorders | ds Navigator | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg | Drug | Avandamet test product |
|
| 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) |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Reference Product |
Reference product: Rosiglitazone Maleate 2 mg in both periods |
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng/ml | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng.h/ml | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng.h/ml | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng.h/ml | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng/ml | Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) |
|
|
|
|
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Reference Product in Period 1; Test Product in Period 2 | Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2 | 0 | 13 | 13 | 13 |
| Tension cephalea | General disorders | ds Navigator | Systematic Assessment |
|
| Frontal cephalea | General disorders | ds Navigator | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Diarrhea with semi liquid stool | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
|
| Evacuation of liquid stool | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
|
| Post-study increased urea | Renal and urinary disorders | ds Navigator | Systematic Assessment |
|
| Post-study altered urine exam | Renal and urinary disorders | ds Navigator | Systematic Assessment |
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| Post-study increased leucocytes | Blood and lymphatic system disorders | ds Navigator | Systematic Assessment |
|
| Post-study increased total cholesterol | Blood and lymphatic system disorders | ds Navigator | Systematic Assessment |
|
| Post-study increased triglycerides | Blood and lymphatic system disorders | ds Navigator | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |