Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501

• Registration Number: NCT03089112
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Study Start: 2017-03-31
• Primary Completion: 2017-05-28
• Study Completion: 2017-06-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• 1.age 19~40 years
• 2.The result of BMI is not less than 19 kg/m2 , no more than 28 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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Seguence 1	HGP1607	Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Seguence 1	HGP1501	Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Seguence 1	HGP1607+HGP1501	Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Seguence 2	HGP1607	Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Seguence 2	HGP1501	Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Seguence 2	HGP1607+HGP1501	Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Seguence 3	HGP1607	Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Seguence 3	HGP1501	Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Seguence 3	HGP1607+HGP1501	Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Seguence 4	HGP1607+HGP1501	Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Seguence 5	HGP1607	Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Seguence 5	HGP1501	Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Seguence 5	HGP1607+HGP1501	Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Seguence 6	HGP1501	Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607
Seguence 4	HGP1607	Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Seguence 4	HGP1501	Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Seguence 6	HGP1607+HGP1501	Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607
Seguence 6	HGP1607	Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607

Primary Outcome Measures

Name	Time	Method
AUClast of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary Outcome Measures

Name	Time	Method
AUCinf of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Tmax of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
T1/2 of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
AUClast of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Cmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected AUCinf of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Tmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected T1/2 of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Trial Locations

Locations (1)

Seoul Asan Hospital; 🇰🇷 Seoul, Korea, Republic of