NCT03944200

A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State

Randomized, Open Label, Single Oral Administration at Fed State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A study demonstrates the bioequivalence of DA-1229\_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	DA-1229_01(A), Sugamet SR Tab 5/1000mg®	Period 1: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
DRUG	Sugamet SR Tab 5/1000mg®, DA-1229_01(A)	Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.

Timeline

• Start date: 2019-02-07
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2019-05-09
• Last updated: 2020-05-20

Locations

1 site across 1 country: South Korea