A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.
- Registration Number
- NCT04322266
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- Age 19~45 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
- Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 (Reference-Test) HCP1701 Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 Sequence 1 (Reference-Test) HCP1306 Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 Sequence 1 (Reference-Test) HGP0608 Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 Sequence 2 (Test-Reference) HCP1701 Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608 Sequence 2 (Test-Reference) HGP0608 Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608 Sequence 1 (Reference-Test) HGP0904 Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 Sequence 2 (Test-Reference) HGP0904 Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608 Sequence 2 (Test-Reference) HCP1306 Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608
- Primary Outcome Measures
Name Time Method AUClast of EXP3174 Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours Pharmacokinetic evaluation
AUClast of Losartan Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours Pharmacokinetic evaluation
Cmax of Rosuvastatin Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
Cmax of EXP3174 Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours Pharmacokinetic evaluation
Cmax of Amlodipine Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours Pharmacokinetic evaluation
AUClast of Amlodipine Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours Pharmacokinetic evaluation
Cmax of Losartan Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours Pharmacokinetic evaluation
AUClast of Rosuvastatin Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
Cmax of Free Ezetimibe Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
AUClast of Free Ezetimibe Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method AUClast of Total Ezetimibe Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
Cmax of Total Ezetimibe Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours Pharmacokinetic evaluation
Trial Locations
- Locations (1)
Korea University Hospital (Anam)
🇰🇷Seoul, Korea, Republic of
Korea University Hospital (Anam)🇰🇷Seoul, Korea, Republic of