Pharmacokinetics and Safety Profile of CKD-333

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: CKD-333 formulation I; Drug: CKD-330+D086; Drug: CKD-333 formulation II

Study type: Interventional

Funder types: Industry

Identifiers

NCT03659149

170PK18015

Details and patient eligibility

About

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

Full description

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

Enrollment: 37 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 6 patient groups

Group 1

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I

Group 2

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I

Group 3

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I

Group 4

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I

Group 5

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I

Group 6

Experimental group

Description:

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)

Treatment:

Drug: CKD-333 formulation II

Drug: CKD-330+D086

Drug: CKD-333 formulation I