Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: HGP1607+HGP1501; Drug: HGP1607; Drug: HGP1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT03089112

HM-BAVI-101

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Seguence 1

Experimental group

Description:

Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501

Seguence 2

Experimental group

Description:

Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501

Seguence 3

Experimental group

Description:

Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501

Seguence 4

Experimental group

Description:

Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501

Seguence 5

Experimental group

Description:

Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501

Seguence 6

Experimental group

Description:

Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607

Treatment:

Drug: HGP1607

Drug: HGP1607+HGP1501

Drug: HGP1501