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

NCT07675226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Bioequivalence Study in Healthy Subjects
  • Immune Thrombocytopenia (ITP)
  • Rheumatoid Arthritis (RA)

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

Sponsors & Collaborators

  • Oscotec Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675226 on ClinicalTrials.gov