Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers

Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers

To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HCP0605 + HGP0816; Drug: HCP1305

Detailed Description

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1 : HCP0605+HGP0816 Period 2 : HCP1305	Drug: HCP0605 + HGP0816; Drug: HCP1305
Experimental: Sequence B; Period 1 : HCP1305 Period 2 : HCP0605+HGP0816	Drug: HCP0605 + HGP0816; Drug: HCP1305

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	Area under the curve to the last measurable concentration	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Cmax	Peak Plasma Concentration	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Area under the curve to infinity	pre-dose(0h), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Tmax	Time to maximum concentration	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
T1/2	Terminal elimination half-life	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Cl/F	Apparent clearance	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Vz/F	Apparent volume of distribution	pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HM-ALRO-102