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

Sponsor
SK Chemicals Co., Ltd.
Study ID
NCT05236998
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SID1903 (FDC) — DRUG
    Single oral administration of SID1903 (FDC) after an overnight fast
  • Dapagliflozin and Sitagliptin — DRUG
    Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Study Details

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.

Key Dates

Start date
Nov 3, 2021
Status verified
Feb 2022
Primary completion
Dec 21, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A
    Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC)
  • Experimental: Sequence B
    Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin

Primary Outcome Measure

AUC0-t [ Time Frame: up to 72 hours ]

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