A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2)

Phase 1

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: CKD-391(2); Drug: CKD-331, D337

• Registration Number: NCT06088017
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391(2)

Detailed Description

A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391(2) and co-administration of CKD-331 and D337 in healthy adult volunteers

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-10-23
• Primary Completion: 2024-01-07
• Study Completion: 2024-01-22
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	CKD-391(2)	* Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
Sequence 1	CKD-331, D337	* Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
Sequence 2	CKD-391(2)	* Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
Sequence 2	CKD-331, D337	* Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition * Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition * Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition

Primary Outcome Measures

Name	Time	Method
AUCt of CKD-391(2)	Pre-dose(0 hour) to 72hours	Area under the concentration-time curve time zero to time
Cmax of CKD-391(2)	Pre-dose(0 hour) to 72hours	Maximum plasma concentration of the drug

Trial Locations

Locations (1)

Bumin hopspital, Seoul; 🇰🇷 Seoul, Gangseo-gu, Korea, Republic of