Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HIP1403; Drug: HGP0919

Study type: Interventional

Funder types: Industry

Identifiers

NCT02941731

HM-OSVI-101

Details and patient eligibility

About

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.

Full description

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 suspensions in healthy male volunteers.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 29 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. Positive serology for HBs antigen, HCV antibody, HIV antigen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Sequence 1

Experimental group

Description:

HIP1403→HGP0919

Treatment:

Drug: HGP0919

Drug: HIP1403

Sequence 2

Experimental group

Description:

HGP0919→HIP1403

Treatment:

Drug: HGP0919

Drug: HIP1403