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Pharmacokinetics and Safety Profile of CKD-333

NCT ID: NCT03659149

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2018-10-12

Brief Summary

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Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Detailed Description

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An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Conditions

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Hypertension Dyslipidemias

Keywords

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Hypertension Dyslipidemias CKD-333

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Group 2

Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Group 3

Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Group 4

Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Group 5

Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Group 6

Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)

Group Type EXPERIMENTAL

CKD-333 formulation I

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation II

Intervention Type DRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086

Intervention Type DRUG

2 tablet administered before the breakfast(single-dose)

Interventions

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CKD-333 formulation I

1 tablet administered before the breakfast(single-dose)

Intervention Type DRUG

CKD-333 formulation II

1 tablet administered before the breakfast(single-dose)

Intervention Type DRUG

CKD-330+D086

2 tablet administered before the breakfast(single-dose)

Intervention Type DRUG

Other Intervention Names

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Test drug Test drug Reference drug

Eligibility Criteria

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Inclusion Criteria

1. Between 19 aged and 45 aged in healthy male adult
2. Body weight more than 50kg and within ideal body weight ±20%

Exclusion Criteria

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. SBP(Systolic Blood pressure)≥140mmHg or SBP\<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP\<60mmHg
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seunghun Han, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Seoul ST.Mayr's Hospital

Locations

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Seoul Saint Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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170PK18015

Identifier Type: -

Identifier Source: org_study_id