NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	19/04/2012
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SMP-508 (repaglinide) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Pharmacokinetics To assess the pharmacokinetics of SMP-508 or sitagliptin given in co-administration and .single administration.
Secondary Outcome	Safety To investigate the safety of co-administration of SMP-508 and sitagliptin.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 40age old
Gender	Male
Include criteria	Subject Healthy adult male volunteers Inclusion criteria - Subjects who provided written informed consent to participate in the study. - Subjects whose body weight are between 50.0 and 80.0 kg and whose body mass index (BMI) are 18.5 to 25.0 {BMI = body weight (kg) / [height (m)]2} etc.
Exclude criteria	Exclusion criteria - Subjects with a history of drug allergies. - Subjects with any alcohol abuse. etc