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.
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
1 other identifier
interventional
61
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Dec 2018
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedFirst Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedMarch 26, 2020
March 1, 2020
2 months
September 9, 2019
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (10)
Cmax of Amlodipine
Pharmacokinetic evaluation
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
AUClast of Amlodipine
Pharmacokinetic evaluation
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
Cmax of Losartan
Pharmacokinetic evaluation
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
AUClast of Losartan
Pharmacokinetic evaluation
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
Cmax of Rosuvastatin
Pharmacokinetic evaluation
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
AUClast of Rosuvastatin
Pharmacokinetic evaluation
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
Cmax of Free Ezetimibe
Pharmacokinetic evaluation
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
AUClast of Free Ezetimibe
Pharmacokinetic evaluation
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
Cmax of EXP3174
Pharmacokinetic evaluation
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
AUClast of EXP3174
Pharmacokinetic evaluation
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
Secondary Outcomes (2)
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
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
Study Arms (2)
Sequence 1 (Reference-Test)
EXPERIMENTALPeriod1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701
Sequence 2 (Test-Reference)
EXPERIMENTALPeriod1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608
Interventions
Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Hospital (Anam)
Seoul, South Korea
Related Publications (1)
Park JW, Chung H, Kim JM, Kim NY, Hong SH, Kim KA, Park JY. Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. Drugs R D. 2024 Jun;24(2):179-186. doi: 10.1007/s40268-024-00460-y. Epub 2024 May 22.
PMID: 38775910DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2019
First Posted
March 26, 2020
Study Start
December 21, 2018
Primary Completion
February 13, 2019
Study Completion
February 13, 2019
Last Updated
March 26, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share