A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04762407
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 18.1

Study Details

Study Description

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HGP1910; Drug: HGP1909; Drug: HCP1903	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 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 Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903 in Healthy Subjects
• Actual Study Start Date: Nov 20, 2020
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903	Drug: HGP1910; Take it once per period.; Drug: HGP1909; Take it once per period.; Drug: HCP1903; Take it once per period.
Experimental: Sequence 2 Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909	Drug: HGP1910; Take it once per period.; Drug: HGP1909; Take it once per period.; Drug: HCP1903; Take it once per period.

Outcome Measures

Primary Outcome Measures

1. Cmax of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

2. AUClast of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

3. Cmax of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

4. AUClast of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

Secondary Outcome Measures

1. Cmax of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

2. AUClast of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

3. AUCinf of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

4. Tmax of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

5. t1/2 of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

6. CL/F of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

7. Vd/F of Rosuvastatin [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

8. AUCinf of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

9. Tmax of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

   pharmacokinetic evaluation

10. t1/2 of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

11. CL/F of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

12. Vd/F of Free Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

13. AUCinf of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

14. Tmax of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

15. t1/2 of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

16. CL/F of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    pharmacokinetic evaluation

17. Vd/F of Total Ezetimibe [pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour]

    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 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 Anam Hospital	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: NCT04762407
• Other Study ID Numbers: HM-ROZE-103
• First Posted: Feb 21, 2021
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• 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 Jul 14, 2022