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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

• Registration Number: NCT04272502
• 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, D326 and D337 in healthy adult volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-04
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence C	CKD-348 F1, CKD-348 F2, CKD-828, D326, D337	CKD-828, D326, D337, CKD-F1, CKD-F2
Sequence A	CKD-348 F1, CKD-348 F2, CKD-828, D326, D337	CKD-828, D326, D337, CKD-F1, CKD-F2
Sequence B	CKD-348 F1, CKD-348 F2, CKD-828, D326, D337	CKD-828, D326, D337, CKD-F1, CKD-F2

Primary Outcome Measures

Name	Time	Method
Cmax	0 hour ~ 144 hour	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; 🇰🇷 Gyeonggi-do, Korea, Republic of