Trial Outcomes & Findings for Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects (NCT NCT02276274)
NCT ID: NCT02276274
Last Updated: 2023-09-21
Results Overview
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
COMPLETED
PHASE3
12 participants
3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
2023-09-21
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 21 June 2014 to 22 July 2014.
Healthy participants were enrolled in 1 of 2 treatment groups: SYR-322-MET fasted followed by SYR-322-MET fed; SYR-322-MET fed followed by SYR-322-MET fasted.
Participant milestones
| Measure |
SYR-322-MET Fasted Followed by SYR-322-MET Fed
A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
|
SYR-322-MET Fed Followed by SYR-322-MET Fasted
A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
|
|---|---|---|
|
First Intervention Period
STARTED
|
6
|
6
|
|
First Intervention Period
COMPLETED
|
6
|
6
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
|
Washout Period (at Least 15 Days)
STARTED
|
6
|
6
|
|
Washout Period (at Least 15 Days)
COMPLETED
|
6
|
6
|
|
Washout Period (at Least 15 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
6
|
6
|
|
Second Intervention Period
COMPLETED
|
6
|
6
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
Baseline characteristics by cohort
| Measure |
SYR-322-MET Fasted Followed by SYR-322-MET Fed
n=6 Participants
A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
|
SYR-322-MET Fed Followed by SYR-322-MET Fasted
n=6 Participants
A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.43 • n=7 Participants
|
25.2 years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
height
|
168.5 centimeters (cm)
STANDARD_DEVIATION 6.98 • n=5 Participants
|
175.7 centimeters (cm)
STANDARD_DEVIATION 6.68 • n=7 Participants
|
172.1 centimeters (cm)
STANDARD_DEVIATION 7.51 • n=5 Participants
|
|
Weight
|
61.17 kilogram (kg)
STANDARD_DEVIATION 8.373 • n=5 Participants
|
65.40 kilogram (kg)
STANDARD_DEVIATION 6.425 • n=7 Participants
|
63.28 kilogram (kg)
STANDARD_DEVIATION 7.451 • n=5 Participants
|
|
Body Mass Index (BMI)
|
21.48 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.878 • n=5 Participants
|
21.15 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.869 • n=7 Participants
|
21.32 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.406 • n=5 Participants
|
|
Smoking Classification
Never Smoked
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Smoking Classification
Current Smoker
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Smoking Classification
Ex-Smoker
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Alcohol Classification
Drank Every Day
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Alcohol Classification
Drank a Few Days per Week
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Alcohol Classification
Drank a Few Days per Month
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Alcohol Classification
No
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Caffeine Classification
Took Caffeine
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Caffeine Classification
Did not take Caffeine
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)
|
1494.9 nanogram*milliliter per hour (ng*hr/mL)
Standard Deviation 159.42
|
1472.8 nanogram*milliliter per hour (ng*hr/mL)
Standard Deviation 172.59
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z
|
1494.9 ng*hr/mL
Standard Deviation 159.42
|
1472.8 ng*hr/mL
Standard Deviation 172.59
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for SYR-322Z
|
154.9 ng/mL
Standard Deviation 38.72
|
173.4 ng/mL
Standard Deviation 38.45
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z
|
3.000 hour (hr)
Interval 2.0 to 4.0
|
1.00 hour (hr)
Interval 0.5 to 3.0
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z
|
1555.0 ng*hr/mL
Standard Deviation 167.20
|
1536.8 ng*hr/mL
Standard Deviation 187.33
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z
|
0.03912 hr^-1
Standard Deviation 0.0046649
|
0.03673 hr^-1
Standard Deviation 0.0053316
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for SYR-322Z
|
17.94 hr
Standard Deviation 2.0527
|
19.24 hr
Standard Deviation 2.8931
|
PRIMARY outcome
Timeframe: 3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administrationPopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z
|
16.24 L/hr
Standard Deviation 1.6898
|
16.52 L/hr
Standard Deviation 2.2647
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). (AUMC \[0-inf\]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Mean Residence Time (MRT) for SYR-322Z
|
18.06 hr
Standard Deviation 1.4216
|
17.72 hr
Standard Deviation 2.1696
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z
|
14.84 hr
Standard Deviation 1.2056
|
14.17 hr
Standard Deviation 1.1703
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II
M-II
|
39.18 ng*hr/mL
Standard Deviation 26.439
|
37.00 ng*hr/mL
Standard Deviation 26.048
|
|
AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II
M-I
|
9.49 ng*hr/mL
Standard Deviation 7.746
|
8.28 ng*hr/mL
Standard Deviation 6.862
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II
M-II
|
38.48 ng*hr/mL
Standard Deviation 26.579
|
36.00 ng*hr/mL
Standard Deviation 25.861
|
|
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II
M-I
|
8.93 ng*hr/mL
Standard Deviation 7.828
|
7.72 ng*hr/mL
Standard Deviation 6.906
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II
M-I (n= 11, 11)
|
17.95 hr
Standard Deviation 6.3662
|
17.75 hr
Standard Deviation 6.7278
|
|
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II
M-II (n=12, 12)
|
10.88 hr
Standard Deviation 1.6364
|
10.45 hr
Standard Deviation 1.7285
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II
M-I
|
0.42 ng/mL
Standard Deviation 0.295 • Interval 1.5 to 4.0
|
0.40 ng/mL
Standard Deviation 0.319 • Interval 1.0 to 4.0
|
|
Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II
M-II
|
4.18 ng/mL
Standard Deviation 3.052 • Interval 3.0 to 4.0
|
3.58 ng/mL
Standard Deviation 2.525 • Interval 1.5 to 3.0
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II
M-I (n = 11, 11)
|
3.000 hr
Full Range 9.168 • Interval 1.5 to 4.0
|
1.500 hr
Full Range 6.369 • Interval 1.0 to 4.0
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II
M-II (n = 12, 12)
|
3.000 hr
Full Range 27.226 • Interval 3.0 to 4.0
|
2.500 hr
Full Range 26.671 • Interval 1.5 to 3.0
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II
M-I (n = 9, 9)
|
15.86 ng*hr/mL
Standard Deviation 9.168
|
14.53 ng*hr/mL
Standard Deviation 6.369
|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II
M-II (n = 12, 12)
|
40.28 ng*hr/mL
Standard Deviation 27.226
|
38.01 ng*hr/mL
Standard Deviation 26.671
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II
M-I (n = 9, 9)
|
0.02711 hr^-1
Standard Deviation 0.0039065
|
0.02708 hr^-1
Standard Deviation 0.0081278
|
|
Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II
M-II (n = 12, 12)
|
0.06458 hr^-1
Standard Deviation 0.023460
|
0.06651 hr^-1
Standard Deviation 0.021985
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II
M-I (n = 9, 9)
|
26.09 hr
Standard Deviation 3.9939
|
31.39 hr
Standard Deviation 22.996
|
|
Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II
M-II (n = 12, 12)
|
12.43 hr
Standard Deviation 5.4904
|
11.70 hr
Standard Deviation 4.5855
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II
M-I (n = 9, 9)
|
39.87 hr
Standard Deviation 6.1272
|
49.97 hr
Standard Deviation 38.556
|
|
Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II
M-II (n = 12, 12)
|
13.93 hr
Standard Deviation 2.2797
|
13.81 hr
Standard Deviation 2.1894
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin
|
9157.3 ng*hr/mL
Standard Deviation 1684.53
|
8991.8 ng*hr/mL
Standard Deviation 1284.97
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin
|
9038.8 ng*hr/mL
Standard Deviation 1661.09
|
8853.8 ng*hr/mL
Standard Deviation 1271.92
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: Subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin
|
5.697 hr
Standard Deviation 0.75798
|
5.697 hr
Standard Deviation 0.58215
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Metformin
|
1473.3 ng/mL
Standard Deviation 300.19
|
1251.7 ng/mL
Standard Deviation 164.03
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin
|
3.000 hr
Interval 0.5 to 4.0
|
3.000 hr
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin
|
9195.3 ng*hr/mL
Standard Deviation 1669.37
|
8997.4 ng*hr/mL
Standard Deviation 1289.67
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz) for Metformin
|
0.1366 hr^-1
Standard Deviation 0.028295
|
0.1638 hr^-1
Standard Deviation 0.027820
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for Metformin
|
5.290 hr
Standard Deviation 1.1735
|
4.338 hr
Standard Deviation 0.70681
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin
|
55.84 L/hr
Standard Deviation 9.0078
|
56.75 L/hr
Standard Deviation 9.1099
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Mean Residence Time (MRT) for Metformin
|
6.213 hr
Standard Deviation 0.88315
|
6.097 hr
Standard Deviation 0.63435
|
PRIMARY outcome
Timeframe: 0 to 12 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose
|
42.609 percentage of dose
Standard Deviation 4.9985
|
45.028 percentage of dose
Standard Deviation 6.9388
|
PRIMARY outcome
Timeframe: 0 to 24 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose
|
58.618 percentage of dose
Standard Deviation 4.0606
|
59.886 percentage of dose
Standard Deviation 6.5474
|
PRIMARY outcome
Timeframe: 0 to 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose
|
70.200 percentage of dose
Standard Deviation 3.8051
|
71.148 percentage of dose
Standard Deviation 6.4985
|
PRIMARY outcome
Timeframe: 0 to 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose
|
73.728 percentage of dose
Standard Deviation 3.9140
|
74.547 percentage of dose
Standard Deviation 6.4048
|
PRIMARY outcome
Timeframe: 0 to 12 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose
M-I
|
0.235 percentage of dose
Standard Deviation 0.1393
|
0.234 percentage of dose
Standard Deviation 0.1719
|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose
M-II
|
1.202 percentage of dose
Standard Deviation 0.8060
|
1.145 percentage of dose
Standard Deviation 0.7826
|
PRIMARY outcome
Timeframe: 0 to 24 hours post dosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose
M-I
|
0.394 percentage of dose
Standard Deviation 0.2386
|
0.363 percentage of dose
Standard Deviation 0.2482
|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose
M-II
|
1.562 percentage of dose
Standard Deviation 1.0106
|
1.502 percentage of dose
Standard Deviation 0.9879
|
PRIMARY outcome
Timeframe: 0 to 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose
M-I
|
0.535 percentage of dose
Standard Deviation 0.3441
|
0.495 percentage of dose
Standard Deviation 0.3352
|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose
M-II
|
1.788 percentage of dose
Standard Deviation 1.1384
|
1.732 percentage of dose
Standard Deviation 1.1284
|
PRIMARY outcome
Timeframe: 0 to 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose
M-I
|
0.588 percentage of dose
Standard Deviation 0.3884
|
0.536 percentage of dose
Standard Deviation 0.3816
|
|
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose
M-II
|
1.853 percentage of dose
Standard Deviation 1.1929
|
1.796 percentage of dose
Standard Deviation 1.1696
|
PRIMARY outcome
Timeframe: 0 to 12 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose
|
45.143 percentage of dose
Standard Deviation 7.7692
|
44.809 percentage of dose
Standard Deviation 7.4874
|
PRIMARY outcome
Timeframe: 0 to 24 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose
|
50.078 percentage of dose
Standard Deviation 7.5995
|
49.923 percentage of dose
Standard Deviation 7.5189
|
PRIMARY outcome
Timeframe: 0 to 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose
|
50.626 percentage of dose
Standard Deviation 7.6377
|
50.067 percentage of dose
Standard Deviation 7.6636
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
CLr: Renal Clearance of SYR-322Z
|
11.96 L/hr
Standard Deviation 1.2071
|
12.33 L/hr
Standard Deviation 2.2296
|
PRIMARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.
CLr is a measure of apparent clearance of the drug from the urine.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
CLr: Renal Clearance of Metformin
|
27.88 L/hr
Standard Deviation 4.1525
|
28.34 L/hr
Standard Deviation 6.3364
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.
DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
Predose
|
0.00 percentage of inhibition
Standard Deviation 0.000
|
0.00 percentage of inhibition
Standard Deviation 0.000
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
0.25 hour
|
68.00 percentage of inhibition
Standard Deviation 26.599
|
57.99 percentage of inhibition
Standard Deviation 32.209
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
0.5 hour
|
85.65 percentage of inhibition
Standard Deviation 17.721
|
90.31 percentage of inhibition
Standard Deviation 7.533
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
1 hour
|
91.05 percentage of inhibition
Standard Deviation 4.070
|
95.27 percentage of inhibition
Standard Deviation 2.371
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
1.5 hour
|
91.85 percentage of inhibition
Standard Deviation 2.342
|
95.79 percentage of inhibition
Standard Deviation 0.710
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
2 hour
|
93.63 percentage of inhibition
Standard Deviation 2.028
|
95.58 percentage of inhibition
Standard Deviation 0.542
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
3 hour
|
95.52 percentage of inhibition
Standard Deviation 1.528
|
94.71 percentage of inhibition
Standard Deviation 0.611
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
4 hour
|
94.88 percentage of inhibition
Standard Deviation 1.216
|
93.78 percentage of inhibition
Standard Deviation 0.877
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
6 hour
|
93.04 percentage of inhibition
Standard Deviation 0.708
|
92.06 percentage of inhibition
Standard Deviation 0.880
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
8 hour
|
91.78 percentage of inhibition
Standard Deviation 0.890
|
90.51 percentage of inhibition
Standard Deviation 1.071
|
|
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
24 hour
|
81.74 percentage of inhibition
Standard Deviation 2.235
|
81.38 percentage of inhibition
Standard Deviation 2.614
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.
DPP-4 activity was assessed from the plasma samples collected from the participants.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
DPP-4 Activity
0.25 hour
|
2.5833 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 2.37291
|
3.4518 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 2.86390
|
|
DPP-4 Activity
0.5 hour
|
1.1944 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 1.64100
|
0.7823 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.66267
|
|
DPP-4 Activity
1 Hour
|
0.7122 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.39573
|
0.3737 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.21081
|
|
DPP-4 Activity
1.5 Hour
|
0.6366 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.19955
|
0.3312 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.07085
|
|
DPP-4 Activity
2 hours
|
0.5003 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.17621
|
0.3475 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.05993
|
|
DPP-4 Activity
3 hours
|
0.3575 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.14924
|
0.4128 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.06132
|
|
DPP-4 Activity
Predose
|
7.8167 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.85551
|
7.8492 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.99173
|
|
DPP-4 Activity
4 hours
|
0.3977 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.09285
|
0.4873 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.08441
|
|
DPP-4 Activity
6 hours
|
0.5423 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.07347
|
0.6196 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.08548
|
|
DPP-4 Activity
8 hours
|
0.6422 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.09457
|
0.7425 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.11652
|
|
DPP-4 Activity
24 hours
|
1.4275 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.22071
|
1.4550 nanomole/minute/milliliter (nmoL/min/mL)
Standard Deviation 0.24055
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.
Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours
|
2114.62 percentage of inhibition*hour
Standard Deviation 30.355
|
2100.74 percentage of inhibition*hour
Standard Deviation 27.297
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.
Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity
|
96.10 percentage of inhibition
Standard Deviation 1.022
|
96.33 percentage of inhibition
Standard Deviation 0.779
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.
Time to reach Emax for the first time was determined from the inhibition-time curve.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Tmax: Time to Reach Emax
|
3.000 hour
Interval 2.0 to 4.0
|
1.000 hour
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: Baseline up to the day of discharge (Day 4) in the second intervention periodPopulation: Safety analysis set: All participants who receive at least one dose of study medication.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Number of Participants Reporting 1 or More Treatment-emergent Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdosePopulation: Safety analysis set: All participants who receive at least one dose of study medication.
Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic \[Millimeters of mercury\]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose), 24 and 72 hours postdosePopulation: Safety analysis set: All participants who receive at least one dose of study medication.
Clinically significant change participant's body weight observed at any time point are reported.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Body Weight
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdosePopulation: Safety analysis set: All participants who receive at least one dose of study medication.
Clinically significant change in electrocardiograms observed at any time point are reported.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Number of Participants With Significant Change From Baseline in Electrocardiograms
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 hours prior to administration (predose), 24 and 72 hours postdosePopulation: Safety analysis set: All participants who receive at least one dose of study medication.
Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.
Outcome measures
| Measure |
SYR-322-MET Fasted
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
|
SYR-322-MET Fed
n=12 Participants
SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
|
|---|---|---|
|
Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)
|
0 participants
|
0 participants
|
Adverse Events
SYR-322-MET Fasted
SYR-322-MET Fed
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER