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.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1701; Drug: HCP1306; Drug: HGP0904; Drug: HGP0608

• 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

Study Timeline

• Study Start: 2018-12-21
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Study First Submitted: 2019-09-09
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-25
• Last Update Submitted: 2020-03-25
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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

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