A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study.
      The objective of the study is to compare the pharmacokinetic properties after
      co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of
      combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy
      male volunteers.
    

Detailed description: 
      This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study.
      The objective of the study is to compare the pharmacokinetic properties after
      co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of
      combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy
      male volunteers.

        -  All the subjects should be admitted one day prior to scheduled study date until 4pm to
           Chonbuk National University Hospital Clinical Trial Center and they will be served with
           the same dinner. After dinner, they should keep fast, they are just allowed to drink
           water until 8am of the study date.

             -  According to the randomly designated order, all subjects will be administrated with
                the study or reference products with 240mL of water at 9am(±2hours) on the first
                date of the study. The study or the reference products should be swallowed
                completely, and not to be chewed before swallowing.

                  -  Study product : Repanorm M 2/500mg (Dalim BioTech Co., Ltd.)

                  -  Reference products : Metformin HCl 500mg tablet, Repaglinide 2mg tablet

                       -  Subjects have to fast for 4 hours post administration of the study or
                          reference drugs(water intake is not allowed for 1 hour before and after
                          the administration), and should follow standardized lunch after four
                          hours and dinner 9 hours later from the time of administration

                            -  Assessment and laboratory test will be performed in accordance with
                               schedule written on the protocol

                                 -  After having 7 days of withdrawal period, the 2nd study period
                                    will be done at 9am(±2hours). In contrast of the 1st period,
                                    Sequence B which received the study product in 1st period will
                                    take the reference drugs for the 2nd period, while the group
                                    Sequence A which received reference drugs will take the study
                                    drug. The steps of administration of drugs and process of tests
                                    are the same with the 1st period
    

Intervention name(s): Repaglinide/Metformin combination, Repaglinide, Metformin; Repaglinide/Metformin combination, Repaglinide, Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1.
Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2.; Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1.
Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2.
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Pharmacokinetics