A Randomized, Open-label, Crossover Study to Determine the 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

Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2014
INTERVENTION: Intervention name : SYR‐322‐MET Dosage And administration of the intervention : Oral CONDITION: Healthy adult male subjects PRIMARY OUTCOME: Pharmacokinetics of unchanged SYR‐322(SYR‐322Z) and its main metabolites (M‐I and M‐II); Pharmacokinetics of metformin SECONDARY OUTCOME: Pharmacodynamic endpoints: DPP‐4 activity and inhibition rate of DPP‐4 activity; Safety endpoints: adverse events, vital signs, body weight, 12‐lead ECG findings, and clinical laboratory test values INCLUSION CRITERIA: 1.In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements. 2.The subject signs and dates a written, informed consent form prior to the initiation of any study procedures. 3.The subject is a Japanese healthy adult male. 4.The subject is aged 20 to 35 years, inclusive, at the time of informed consent. 5.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.
Epistemonikos ID: a54279319c12f7c153d6e6ffbf2607454ced1fc6
First added on: Aug 23, 2024