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Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04272502
Enrollment
15
Registered
2020-02-17
Start date
2019-06-04
Completion date
2019-08-26
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Interventions

DRUGCKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Each arm has a different order for taking IP

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. 19 ≤ age ≤ 45 2. Health Volunteers 3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

1\. Subject who cannot participate in a clinical trial based on the PI's judgment

Design outcomes

Primary

MeasureTime frameDescription
Cmax0 hour ~ 144 hourMaximum plasma concentration of the drug
AUCt0 hour ~ 144 hourArea under the concentration-time curve from time zero to time

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026