Clinical trial NCT03920579: A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Dyslipidemias
Keywords: CKD-386
Pharmacokinetics
D326
D337
D013
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary outcomes:
measure: AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
measure: Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
measure: Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
timeFrame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Clinical Trials Center, Gil Medical Center, Incheon, Korea
name: Dongseong Shin, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: