Conditions: Pharmacokinetics and Pharmacodynamics
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in healthy Korean subjects.

Detailed description:
Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying and inhibiting glucagon secretion.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. As development of alogliptin expands to other countries, additional studies are needed to bridge between the data previously acquired.

The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of alogliptin in healthy Korean participants.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days. intervention 2: Alogliptin 25 mg, tablets, orally, once daily for up to 7 days. intervention 3: Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.

Protocol document: