Clinical trial NCT04081844: A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.
Official title: An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 31
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects


Eligibility criteria: Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. 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.
4. 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:

1. 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
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax,ss of Amlodipine
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of Amlodipine
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmax,ss of Losartan
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of Losartan
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmax,ss of EXP3174
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of EXP3174
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmax,ss of Rosuvastatin
timeFrame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of Rosuvastatin
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmax,ss of Free Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of Free Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmax,ss of Total Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: AUCtau of Total Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Secondary outcomes:
measure: Cmin,ss of Amlodipine
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T max,ss of Amlodipine
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of Amlodipine
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmin,ss of Losartan
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T max,ss of Losartan
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of Losartan
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmin,ss of EXP3174
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T max,ss of EXP3174
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of EXP3174
timeFrame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmin,ss of Rosuvastatin
timeFrame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T max,ss of Rosuvastatin
timeFrame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of Rosuvastatin
timeFrame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmin,ss of Free Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Tmax,ss of Free Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of Free Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Cmin,ss of Total Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: Tmax,ss of Total Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
measure: T1/2 of Total Ezetimibe
timeFrame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital (Anam)
Study officials:
References: