A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers

Phase 1 Completed 51 enrolled SK Chemicals Co., Ltd.

RandomizedCrossoverOpen-labelTreatment

Summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.

Timeline

Start: 2022-06-23
Primary completion: 2022-08-01
Completion: 2022-08-11

Outcome

Met primary endpoint

paper Dapagliflozin/sitagliptin FDC was bioequivalent to IC tablets in both Western and Korean studies PMID 39179458 ↗

paper within the 0.8000-1.2500 bioequivalence criterion limit. PMID 39179458 ↗

Publications

Lukka PB, Tang W, Hammarstedt A, Conrad T, Heijer M, Karlsson C, Boulton DW. Racial Comparison of the Pharmacokinetics and Safety of Fixed-dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. Clin Ther. 2024 Sep;46(9):717-725. doi: 10.1016/j.clinthera.2024.07.007. Epub 2024 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral

Indications

No indication recorded.