Clinical trial NCT04477369: Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
Official title: An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.

Detailed description: The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers aged 19 years old to under 55.
* BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
* Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.

Primary outcomes:
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
timeFrame: 0 - 72 hours after dosing
Secondary outcomes:
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F
timeFrame: 0 - 72 hours after dosing
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F
timeFrame: 0 - 72 hours after dosing
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Hospital
Study officials:
References: