A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: D326, D337 and D013; Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920579

183PK18034

Details and patient eligibility

About

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Full description

A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Enrollment: 30 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion criteria

1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013

Sequence 2

Experimental group

Description:

Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013

Sequence 3

Experimental group

Description:

Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013

Sequence 4

Experimental group

Description:

Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013

Sequence 5

Experimental group

Description:

Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013

Sequence 6

Experimental group

Description:

Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)

Treatment:

Drug: CKD-386 formulation 2

Drug: CKD-386 formulation 1

Drug: D326, D337 and D013