A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903
- Registration Number
- NCT04762407
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 57
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 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 HGP1910 Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903 Sequence 1 HGP1909 Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903 Sequence 1 HCP1903 Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903 Sequence 2 HGP1910 Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909 Sequence 2 HCP1903 Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909 Sequence 2 HGP1909 Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909
- Primary Outcome Measures
Name Time Method AUClast of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Cmax of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
AUClast of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Cmax of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method Cmax of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
AUClast of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
AUCinf of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Tmax of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
t1/2 of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
CL/F of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Vd/F of Rosuvastatin pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
AUCinf of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Tmax of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
t1/2 of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
CL/F of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Vd/F of Free Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
AUCinf of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Tmax of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
t1/2 of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
CL/F of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Vd/F of Total Ezetimibe pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour pharmacokinetic evaluation
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of