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Clinical Trial Details

Trial ID: L6410
Source ID: NCT01332071
Associated Drug: Rosiglitazone Maleate + Metformin 2 Miligrams (Mg) + 500 Mg
Title: Avandamet Bioequivalence Study Brazil - Fed Administration
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01332071/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg|DRUG: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Outcome Measures: 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., 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) |
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2009-11-24
Completion Date: 2009-12-06
Results First Posted: 2011-04-08
Last Update Posted: 2017-07-12
Locations: GSK Investigational Site, Goiania, Goiás, Brazil
URL: https://clinicaltrials.gov/show/NCT01332071