Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01780051
Brief 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
Study:
NCT01780051
Study Brief:
Protocol Section:
NCT01780051