Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

An Open-labeled, Randomized Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Single Oral Administration of HGP0918 and HGP0816 in Healthy Adult Subjects

The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje Busan Paik hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Healthy male volunteers, aged 19 to 55 years.
• The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

Exclusion Criteria:

• 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
• Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
• Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; HGP0918 -> HGP0816 -> HGP0918 + HGP0816	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816
Experimental: Sequence 2; HGP0816 -> HGP0918 + HGP0816 -> HGP0918	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816
Experimental: Sequence 3; HGP0918 + HGP0816 -> HGP0918 -> HGP0816	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816
Experimental: Sequence 4; HGP0918 -> HGP0918 + HGP0816 -> HGP0816	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816
Experimental: Sequence 5; HGP0816 -> HGP0918 -> HGP0918 + HGP0816	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816
Experimental: Sequence 6; HGP0918 + HGP0816 -> HGP0816 -> HGP0918	Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
baseline-corrected Cmax of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
baseline-corrected AUCt of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Cmax of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
AUCt of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUCt of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Tmax of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
t1/2β of HGP0918	-20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUC∞ of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Tmax of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
t1/2β of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
CL/F of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Vdz/F of HGP0816	0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HM-ROMA-105