Trial Outcomes & Findings for Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers (NCT NCT01561976)
NCT ID: NCT01561976
Last Updated: 2017-10-16
Results Overview
Pharmacokinetic (PK) blood samples for estimation of Cmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing
Results posted on
2017-10-16
Participant Flow
This study was conducted at one center in India from 30 January 2012 to 21 February 2012.
A total of 30 participants were enrolled in this study. METLEAD™ Forte SR (metformin hydrochloride prolonged release) and METLEAD™ G2 Forte (metformin hydrochloride sustained release/glimepiride) are registered product of GlaxoSmithKline.
Participant milestones
| Measure |
METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 milligrams (mg)/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1 (day after the dosing day), breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (7 Days)
STARTED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Washout Period 1 (7 Days)
COMPLETED
|
5
|
5
|
4
|
4
|
5
|
4
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Period 2
STARTED
|
5
|
5
|
4
|
4
|
5
|
4
|
|
Period 2
COMPLETED
|
5
|
5
|
4
|
4
|
5
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (7 Days)
STARTED
|
5
|
5
|
4
|
4
|
5
|
4
|
|
Washout Period 2 (7 Days)
COMPLETED
|
4
|
5
|
3
|
4
|
5
|
4
|
|
Washout Period 2 (7 Days)
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
5
|
3
|
4
|
5
|
4
|
|
Period 3
COMPLETED
|
4
|
5
|
3
|
4
|
5
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 milligrams (mg)/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1 (day after the dosing day), breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (7 Days)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period 1 (7 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (7 Days)
Non-compliance
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers
Baseline characteristics by cohort
| Measure |
METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting
n=5 Participants
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte
n=5 Participants
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting
n=5 Participants
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed
n=5 Participants
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte
n=5 Participants
In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
n=5 Participants
In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.2 Years
STANDARD_DEVIATION 5.63 • n=5 Participants
|
25.6 Years
STANDARD_DEVIATION 4.72 • n=7 Participants
|
27.0 Years
STANDARD_DEVIATION 5.79 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 9.31 • n=4 Participants
|
34.6 Years
STANDARD_DEVIATION 6.73 • n=21 Participants
|
25.4 Years
STANDARD_DEVIATION 3.78 • n=10 Participants
|
28.8 Years
STANDARD_DEVIATION 6.63 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Region of Enrollment
India
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population included participants who received study medication. Only those participants available at the indicated time points were analyzed.
Pharmacokinetic (PK) blood samples for estimation of Cmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
884.297 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28.10
|
963.384 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.13
|
942.653 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.16
|
PRIMARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of AUC (0-infinity) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Area Under Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC (0-infinity)]
|
10099.285 Micrograms hour per milliliter (µ.hr/mL)
Geometric Coefficient of Variation 30.31
|
11765.202 Micrograms hour per milliliter (µ.hr/mL)
Geometric Coefficient of Variation 24.99
|
10751.895 Micrograms hour per milliliter (µ.hr/mL)
Geometric Coefficient of Variation 29.76
|
SECONDARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of AUC (0-t) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC (0-t)]
|
9894.580 µ.hr/mL
Geometric Coefficient of Variation 30.48
|
11563.589 µ.hr/mL
Geometric Coefficient of Variation 25.02
|
10546.905 µ.hr/mL
Geometric Coefficient of Variation 29.87
|
SECONDARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of Tmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax)
|
8.00 Hour
Interval 1.0 to 12.0
|
8.00 Hour
Interval 4.5 to 12.0
|
8.00 Hour
Interval 4.5 to 12.0
|
SECONDARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of Tlag were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
PK Lag Time (Tlag)
|
0.00 Hour
Interval 0.0 to 0.0
|
0.00 Hour
Interval 0.0 to 0.52
|
0.50 Hour
Interval 0.0 to 0.52
|
SECONDARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of Kel were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Elimination Constant (Kel)
|
0.162 Fraction/hour
Interval 0.088 to 0.192
|
0.167 Fraction/hour
Interval 0.144 to 0.209
|
0.165 Fraction/hour
Interval 0.135 to 0.192
|
SECONDARY outcome
Timeframe: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosingPopulation: PK Population. Only those participants available at the indicated time points were analyzed.
PK blood samples for estimation of t1/2 were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Terminal Phase Half Life (t1/2)
|
4.281 Hour
Interval 3.604 to 7.915
|
4.155 Hour
Interval 3.321 to 4.804
|
4.199 Hour
Interval 3.61 to 5.153
|
SECONDARY outcome
Timeframe: Up to approximately 24 days (during treatment and washout) after initiation of studyPopulation: PK Population.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or possible drug-induced liver injury.
Outcome measures
| Measure |
METLEAD ForteSR-Fasting
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 Participants
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 Participants
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
METLEAD ForteSR-Fasting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
METLEAD ForteSR-Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
METLEAD G2 Forte
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
METLEAD ForteSR-Fasting
n=24 participants at risk
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state. In the fasting conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD ForteSR-Fed
n=24 participants at risk
Participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
METLEAD G2 Forte
n=24 participants at risk
Participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state. In the fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In the fed condition, breakfast was served at the scheduled time. The dosing of drug took place at the scheduled time followed by lunch, snack and dinner at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
|
|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
4.2%
1/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
|
Gastrointestinal disorders
Upper abdominal pain
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
4.2%
1/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
|
Gastrointestinal disorders
Loose motions
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
4.2%
1/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
0.00%
0/24 • Up to approximately 24 days (during treatment and washout) after initiation of study. On treatment SAEs and non-serious AEs have been presented.
PK population was used for the analysis of safety data.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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