Evaluating the Bioequivalence of HIP1302, HGP1406

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HIP1302; Drug: HGP1406

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545829

HM-POVI-101

Details and patient eligibility

About

The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

Full description

A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Enrollment: 38 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers, age 19 to 50 years
• The result of Body Mass Index(BMI) is not less than 18.0 kg/m2, no more than 27.0 kg/m2
• 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence 1

Experimental group

Description:

HGP1406 → HIP1302

Treatment:

Drug: HIP1302

Drug: HGP1406

Sequence 2

Experimental group

Description:

HIP1302 → HGP1406

Treatment:

Drug: HIP1302

Drug: HGP1406