NCT05236998

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

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of SID1903 (Fixed-dose Combination of Dapagliflozin and Sitagliptin) or Loose Combination in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SID1903 (FDC)	Single oral administration of SID1903 (FDC) after an overnight fast
DRUG	Dapagliflozin and Sitagliptin	Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Timeline

• Start date: 2021-11-03
• Primary completion: 2021-12-21
• Completion: 2021-12-31
• First posted: 2022-02-11
• Last updated: 2022-10-26

Locations

1 site across 1 country: South Korea