Effect of Food on the Pharmacokinetics of Single Oral Dos... | NCT02276274

ID	Type	Description	Link
U1111-1157-8500	Other Identifier	UTN
JapicCTI-142584	Registry Identifier	JapicCTI (Japan)

Status Module

Label	Type	Description	Intervention Names
Fasted dosing followed by fed dosing	Experimental	Oral administration	Drug: SYR-322-MET
Fed dosing followed by fasted dosing	Experimental	Oral administration	Drug: SYR-322-MET

Name	Type	Description	Arm Group Labels	Other Names
SYR-322-MET	Drug	Oral administration of SYR-322-MET	Fasted dosing followed by fed dosing Fed dosing followed by fasted dosing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)	AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.	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
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z	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]).	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
Cmax: Maximum Observed Plasma Concentration for SYR-322Z	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	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
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z	Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.	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
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z	AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.	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

Secondary Outcomes

Measure	Description	Time Frame
Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity	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.	3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements.
The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
The subject is a Japanese healthy adult male.
The subject is aged 20 to 35 years, inclusive, at the time of informed consent.
The subject has a body weight of 50 kg or more with a BMI of ≥18.5 kg/m2 and <25.0 kg/m2 at screening.

Exclusion Criteria:

The subject has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The subject has received SYR-322 or metformin hydrochloride in a previous clinical study or as a therapeutic agent.
The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.
The subject has a known hypersensitivity to drugs.
The subject has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at screening.
The subject has a history of drug abuse or history of alcohol abuse within 2 years prior to the screening visit or unwilling to agree to abstain from alcohol and drugs throughout the study.
Subject has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
Subject has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking DPP-4 inhibitors or biguanides, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
The subject has current or recent [within 24 weeks (168 days) prior to the initiation of study treatment in Period 1] gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
The subject has a history of cancer.
The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.
The subject has poor peripheral venous access.
The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration Period 1.
The subject has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration in Period 1.
The subject has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration in Period 1.
The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 hemoglobin level <12.5 g/dL.
The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 abnormal (clinically significant) 12-lead ECG.
Subject has abnormal screening or prior to the start of study medication administration on Day 1 in Period 1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.
Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Name	Affiliation	Role
General Manager	Takeda Pharmaceutical Company Limited (Japan)	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00023.2± 1.94 BG00127.2± 6.43 BG00225.2± 4.99

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

height

Mean

Standard Deviation

centimeters (cm)

Title

Denominators

Categories

Title	Measurements
	BG000168.5± 6.98 BG001175.7± 6.68 BG002

Weight

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title	Measurements
	BG00061.17± 8.373 BG00165.40± 6.425 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00021.48± 1.878 BG00121.15± 0.869 BG002

Smoking Classification

Number

participants

Title

Denominators

Categories

Never Smoked

Title	Measurements
	BG0002 BG0011 BG002

Alcohol Classification

Number

participants

Title

Denominators

Categories

Drank Every Day

Title	Measurements
	BG0000 BG0010 BG002

Caffeine Classification

Number

participants

Title

Denominators

Categories

Took Caffeine

Title	Measurements
	BG0002 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)

AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.

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.

Posted

Mean

Standard Deviation

nanogram*milliliter per hour (ng*hr/mL)

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG00012 OG00112

Title

Denominators

Categories

Title	Measurements
	OG0001494.9± 159.42 OG0011472.8± 172.59

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Least Squares Mean Difference	-0.0164			2-Sided	90	-0.0592	0.0264			Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.		Superiority or Other (legacy)

Primary

AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z

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]).

Posted

Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Cmax: Maximum Observed Plasma Concentration for SYR-322Z

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Posted

Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

Posted

Median

Full Range

hour (hr)

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z

AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

Posted

Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z

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.

Posted

Mean

Standard Deviation

hr^-1

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Terminal Phase Elimination Half-life (T1/2) for SYR-322Z

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z

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).

Posted

Mean

Standard Deviation

L/hr

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 administration

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Mean Residence Time (MRT) for SYR-322Z

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.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z

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.

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.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Primary

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

AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.

Posted

Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

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

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]).

Posted

Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

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

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Primary

Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Posted

Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

Posted

Median

Full Range

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II

AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

Posted

Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II

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.

Posted

Mean

Standard Deviation

hr^-1

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II

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.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin

AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.

Posted

Mean

Standard Deviation

ng*hr/mL

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin

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]).

Posted

Mean

Standard Deviation

ng*hr/mL

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin

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.

Posted

Mean

Standard Deviation

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Primary

Cmax: Maximum Observed Plasma Concentration for Metformin

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Posted

Mean

Standard Deviation

ng/mL

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

Posted

Median

Full Range

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin

AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

Posted

Mean

Standard Deviation

ng*hr/mL

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Apparent Terminal Elimination Rate Constant (λz) for Metformin

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.

Posted

Mean

Standard Deviation

hr^-1

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Terminal Phase Elimination Half-life (T1/2) for Metformin

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

Posted

Mean

Standard Deviation

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin

CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.

Posted

Mean

Standard Deviation

L/hr

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Mean Residence Time (MRT) for Metformin

Posted

Mean

Standard Deviation

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose

Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 12 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose

Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose

Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 48 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose

Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose

Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 12 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose

Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 24 hours post dose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose

Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 48 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose

Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose

Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 12 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose

Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose

Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.

Posted

Mean

Standard Deviation

percentage of dose

0 to 48 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Primary

CLr: Renal Clearance of SYR-322Z

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.

Posted

Mean

Standard Deviation

L/hr

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

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Primary

CLr: Renal Clearance of Metformin

CLr is a measure of apparent clearance of the drug from the urine.

Posted

Mean

Standard Deviation

L/hr

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 postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Secondary

Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity

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.

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.

Posted

Mean

Standard Deviation

percentage of inhibition

3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Secondary

DPP-4 Activity

DPP-4 activity was assessed from the plasma samples collected from the participants.

Posted

Mean

Standard Deviation

nanomole/minute/milliliter (nmoL/min/mL)

3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Secondary

AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours

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.

Posted

Mean

Standard Deviation

percentage of inhibition*hour

3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Secondary

Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity

Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.

Posted

Mean

Standard Deviation

percentage of inhibition

3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Secondary

Tmax: Time to Reach Emax

Time to reach Emax for the first time was determined from the inhibition-time curve.

Posted

Median

Full Range

hour

3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting 1 or More Treatment-emergent Adverse Events

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.

Safety analysis set: All participants who receive at least one dose of study medication.

Posted

Number

participants

Baseline up to the day of discharge (Day 4) in the second intervention period

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Secondary

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

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.

Safety analysis set: All participants who receive at least one dose of study medication.

Posted

Number

participants

3 hours prior to administration (predose) and 2, 24 and 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Body Weight

Clinically significant change participant's body weight observed at any time point are reported.

Safety analysis set: All participants who receive at least one dose of study medication.

Posted

Number

participants

3 hours prior to administration (predose), 24 and 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Significant Change From Baseline in Electrocardiograms

Clinically significant change in electrocardiograms observed at any time point are reported.

Safety analysis set: All participants who receive at least one dose of study medication.

Posted

Number

participants

3 hours prior to administration (predose) and 2, 24 and 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)

Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.

Safety analysis set: All participants who receive at least one dose of study medication.

Posted

Number

participants

3 hours prior to administration (predose), 24 and 72 hours postdose

ID	Title	Description
OG000	SYR-322-MET Fasted	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.
OG001	SYR-322-MET Fed	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.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SYR-322-MET Fasted	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.			0	12	0	12
EG001	SYR-322-MET Fed	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.			0	12	0	12