Trial Outcomes & Findings for Avandamet Bioequivalence Study Brazil - Fed Administration (NCT NCT01332071)
NCT ID: NCT01332071
Last Updated: 2017-07-12
Results Overview
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.
COMPLETED
PHASE1
26 participants
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
2017-07-12
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Period 1
STARTED
|
13
|
13
|
|
Period 1
COMPLETED
|
13
|
13
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
7-Day Washout Period
STARTED
|
13
|
13
|
|
7-Day Washout Period
COMPLETED
|
13
|
13
|
|
7-Day Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
13
|
13
|
|
Period 2
COMPLETED
|
13
|
13
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avandamet Bioequivalence Study Brazil - Fed Administration
Baseline characteristics by cohort
| Measure |
Participants Receiving Both Test and Reference Product
n=26 Participants
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
|
|---|---|
|
Age, Continuous
|
29.77 Years
STANDARD_DEVIATION 6.80 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
AUC0-t of Rosiglitazone Maleate
|
1731.22 ng per hour per ml (ng.h/ml)
Standard Deviation 510.47
|
1770.93 ng per hour per ml (ng.h/ml)
Standard Deviation 469.14
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
Cmax of Rosiglitazone Maleate
|
265.45 ng/ml
Standard Deviation 44.33
|
270.97 ng/ml
Standard Deviation 48.32
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
AUC0-infinity of Rosiglitazone Maleate
|
1776.28 ng.h/ml
Standard Deviation 519.63
|
1825.35 ng.h/ml
Standard Deviation 494.35
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
AUC0-t of Metformin Hydrochloride
|
9623.4 ng.h/ml
Standard Deviation 2175.4
|
10074.4 ng.h/ml
Standard Deviation 2411.7
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
AUC0-infinity of Metformin Hydrochloride
|
10419.8 ng.h/ml
Standard Deviation 2198.2
|
11063.7 ng.h/ml
Standard Deviation 2798.3
|
PRIMARY outcome
Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)Population: Participants who completed the study
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.
Outcome measures
| Measure |
Test Product
n=26 Participants
Test product: Rosiglitazone Maleate 4 mg in both periods
|
Reference Product
n=26 Participants
Reference product: Rosiglitazone Maleate 2 mg in both periods
|
|---|---|---|
|
Cmax of Metformin Hydrochloride
|
1623.6 ng/ml
Standard Deviation 326.5
|
1663.9 ng/ml
Standard Deviation 370.2
|
Adverse Events
Test Product in Period 1; Reference Product in Period 2
Reference Product in Period 1; Test Product in Period 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product in Period 1; Reference Product in Period 2
n=13 participants at risk
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
|
Reference Product in Period 1; Test Product in Period 2
n=13 participants at risk
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
|
|---|---|---|
|
General disorders
Cephalea
|
23.1%
3/13
|
0.00%
0/13
|
|
General disorders
Tension cephalea
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Frontal cephalea
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13
|
23.1%
3/13
|
|
Gastrointestinal disorders
Diarrhea with semi liquid stool
|
7.7%
1/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Evacuation of liquid stool
|
7.7%
1/13
|
0.00%
0/13
|
|
Renal and urinary disorders
Post-study increased urea
|
7.7%
1/13
|
0.00%
0/13
|
|
Renal and urinary disorders
Post-study altered urine exam
|
92.3%
12/13
|
61.5%
8/13
|
|
Blood and lymphatic system disorders
Post-study increased leucocytes
|
7.7%
1/13
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Post-study increased total cholesterol
|
0.00%
0/13
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Post-study increased triglycerides
|
7.7%
1/13
|
0.00%
0/13
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER