Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Reference drug; Drug: Test drug

• Registration Number: NCT04083872
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This study is a randomized, open-label, fasting, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions.

Detailed Description

To 16 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D744 Test drug: CKD-385 64 mg formulation I Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

Study Timeline

• Study Start: 2019-09-06
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-08
• Study First Posted: 2019-09-10
• Primary Completion: 2019-10-21
• Study Completion: 2019-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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
Group 2	Test drug	1. Period 1: Test drug 2. Period 2: Reference drug
Group 2	Reference drug	1. Period 1: Test drug 2. Period 2: Reference drug
Group 1	Reference drug	1. Period 1: Reference drug 2. Period 2: Test drug
Group 1	Test drug	1. Period 1: Reference drug 2. Period 2: Test drug

Primary Outcome Measures

Name	Time	Method
Area Under Curve last(AUCt)	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours	Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.
Cmax	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours	The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of