Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: CKD-333, formula I; Drug: CKD-330, D090; Drug: CKD-333, formula II

Study type: Interventional

Funder types: Industry

Identifiers

NCT03849287

170PK18039

Details and patient eligibility

About

The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

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 D090 in healthy male adults

Enrollment: 36 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male adults aged 19 to 45 years
2. Body weight more than 50kg and within ideal body weight ±20%
3. signed informed consent form

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. Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<60mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Group 1

Experimental group

Description:

* Period 1: CKD-333, formula I * Period 2: CKD-333, formula II * Period 3: CKD-330, D090

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090

Group 2

Experimental group

Description:

* Period 1: CKD-333, formula I * Period 2: CKD-330, D090 * Period 3: CKD-333, formula II

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090

Group 3

Experimental group

Description:

* Period 1: CKD-333, formula II * Period 2: CKD-330, D090 * Period 3: CKD-333, formula I

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090

Group 4

Experimental group

Description:

* Period 1: CKD-333, formula II * Period 2: CKD-333, formula I * Period 3: CKD-330, D090

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090

Group 5

Experimental group

Description:

* Period 1: CKD-330, D090 * Period 2: CKD-333, formula I * Period 3: CKD-333, formula II

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090

Group 6

Experimental group

Description:

* Period 1: CKD-330, D090 * Period 2: CKD-333, formula II * Period 3: CKD-333, formula I

Treatment:

Drug: CKD-333, formula II

Drug: CKD-333, formula I

Drug: CKD-330, D090