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A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers

NCT05787873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-18

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.

Conditions

  • Healthy

Interventions

DRUG

SIPS-2209-1

QD, PO

DRUG

SIPS-2209-2, SIPS-2209-3

QD, PO

Sponsors & Collaborators

  • Samik Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Young Ee KWON, Ph.D · Samik Pharmaceutical Co. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2022-09-01
Completion
2022-09-21

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 NCT05787873 on ClinicalTrials.gov