Clinical trial NCT03609606: A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
Official title: An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemias
Hypertension
Keywords: Dyslipidemia
Hypertension
CKD-386
Drug-Drug Interaction
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 69
Sex: MALE
Minimum age (years): 20
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 drug interaction between D326, D337, and D013 in healthy male subjects

Detailed description: An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old
2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
3. Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion Criteria:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion
4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
5. Any clinically significant active chronic disease

Primary outcomes:
measure: AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: Cmax,ss(Maximum plasma concentration of the drug at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
Secondary outcomes:
measure: Cmin,ss(Minimum concentration of the drug in plasma at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: Tmax,ss(Time to maximum plasma concentration at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: t1/2(Terminal elimination half-life)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: CLss/F(Apparent total body clearance of the drug from plasma at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: Vd,ss/F(Apparent volume of distribution at steady state)
timeFrame: 0(predose)~24 hours at Day7 and Day28
measure: PTF(Peak-to-trough fluctuation)
timeFrame: 0(predose)~24 hours at Day7 and Day28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital
name: Ji-Young Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: