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.

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04322266
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 34.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP1701; Drug: HCP1306; Drug: HGP0904; Drug: HGP0608	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Dec 21, 2018
• Actual Primary Completion Date: Feb 13, 2019
• Actual Study Completion Date: Feb 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 (Reference-Test) Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701	Drug: HCP1701; Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium; Drug: HCP1306; Ezetimibe /Rosuvastatin; Drug: HGP0904; Amlodipine; Drug: HGP0608; Losartan potassium
Experimental: Sequence 2 (Test-Reference) Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608	Drug: HCP1701; Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium; Drug: HCP1306; Ezetimibe /Rosuvastatin; Drug: HGP0904; Amlodipine; Drug: HGP0608; Losartan potassium

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Hospital (Anam)	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT04322266
• Other Study ID Numbers: HM-AMOS-102
• First Posted: Mar 26, 2020
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 26, 2020