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ACTIVE NOT RECRUITING
NCT07675226
PHASE1

Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions

Sponsor: Oscotec Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.

Official title: An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-07-10

Completion Date

2026-12-31

Last Updated

2026-09-01

Healthy Volunteers

Yes

Interventions

DRUG

SKI-O-703 API in Capsules

SKI-O-703 API in Capsules 100mg

DRUG

SKI-O-703 Formulated Granules in Capsules

SKI-O-703 Formulated Granules in Capsules 200mg

Locations (1)

Oscotec

Seongnam-si, Gyeonggi-do, South Korea