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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337; Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,; Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

• Registration Number: NCT04304547
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence C	CKD-348 T2, CKD-348 T1, CKD-828, D097, D337	CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Sequence B	CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,	CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Sequence A	CKD-828, D097, D337, CKD-348 T1, CKD-348 T2	CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Primary Outcome Measures

Name	Time	Method
Cmax	0 hour ~ 144 hr	Maximum plasma concentration of the drug
AUCt	0 hour ~ 144 hour	Area under the concentration time curve from time zero to time

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of