Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP0605; Drug: HGP1405; Drug: HCP1401

• Registration Number: NCT04252872
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

Detailed Description

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2016-02-23
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

1. Healthy male volunteer, age 19~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who judged ineligible by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	HGP1405	Period 1 : HCP1401 Period 2 : HCP0605+HGP1405
Sequence A	HCP0605	Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Sequence A	HGP1405	Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Sequence A	HCP1401	Period 1 : HCP0605+HGP1405 Period 2 : HCP1401
Sequence B	HCP0605	Period 1 : HCP1401 Period 2 : HCP0605+HGP1405
Sequence B	HCP1401	Period 1 : HCP1401 Period 2 : HCP0605+HGP1405

Primary Outcome Measures

Name	Time	Method
AUClast	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose	Area under the plasma concentration versus time curve
Cmax	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose	Peak Plasma Concentration

Secondary Outcome Measures

Name	Time	Method
AUCinf	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
T1/2	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Cl/F	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Vz/F	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose
Tmax	pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of