Korea University Hospital (Anam)
Seoul, South Korea
Completed
NCT Number: NCT04081844
A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.
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
Completed
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Conditions
Age range
19 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
HCP1306
DrugEzetimibe 10mg / Rosuvastatin 20mg (Rosuzet)
HGP0904
DrugAmlodipine 5mg(Norvasc)
HGP0608
DrugLosartan 100mg(Cozaar)
Primary outcomes
-
Cmax,ss of Amlodipine
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of Amlodipine
Time frame: 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
Pharmacokinetic evaluation
-
Cmax,ss of Losartan
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of Losartan
Time frame: 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
Pharmacokinetic evaluation
-
Cmax,ss of EXP3174
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of EXP3174
Time frame: 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
Pharmacokinetic evaluation
-
Cmax,ss of Rosuvastatin
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of Rosuvastatin
Time frame: 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
Pharmacokinetic evaluation
-
Cmax,ss of Free Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of Free Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
Cmax,ss of Total Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
AUCtau of Total Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
Secondary outcomes
-
Cmin,ss of Amlodipine
Time frame: 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
Pharmacokinetic evaluation
-
T max,ss of Amlodipine
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of Amlodipine
Time frame: 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
Pharmacokinetic evaluation
-
Cmin,ss of Losartan
Time frame: 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
Pharmacokinetic evaluation
-
T max,ss of Losartan
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of Losartan
Time frame: 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
Pharmacokinetic evaluation
-
Cmin,ss of EXP3174
Time frame: 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
Pharmacokinetic evaluation
-
T max,ss of EXP3174
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of EXP3174
Time frame: 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
Pharmacokinetic evaluation
-
Cmin,ss of Rosuvastatin
Time frame: 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
Pharmacokinetic evaluation
-
T max,ss of Rosuvastatin
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of Rosuvastatin
Time frame: 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
Pharmacokinetic evaluation
-
Cmin,ss of Free Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
Tmax,ss of Free Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of Free Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
Cmin,ss of Total Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
Tmax,ss of Total Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
-
T1/2 of Total Ezetimibe
Time frame: 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
Pharmacokinetic evaluation
Sponsors and collaborators
Lead sponsor
Hanmi Pharmaceutical Company Limited
Industry
Registry information
Official study 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
Important dates
- Study start
- 2018
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Sep 9, 2019
- Registry last updated
- Sep 9, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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