Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT07748702
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CKD-339 — DRUG
    QD, PO
  • D311, D107 — DRUG
    QD, PO

Study Details

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.

Key Dates

First listed
Aug 6, 2026
Start date
Aug 20, 2026
Status verified
Jul 2026
Primary completion
Oct 6, 2026
Completion
Oct 12, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A(Reference-Test)
    Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)
  • Experimental: Sequence B(Test-Reference)
    Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)

Primary Outcome Measure

AUCt of CKD-339 [ Time Frame: From 0 to 72 hours postdose ]

Central Contacts

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