Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: HGP1705; Drug: HIP1601

Study type: Interventional

Funder types: Industry

Identifiers

NCT03372850

HM-ESOM-101

Details and patient eligibility

About

This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Full description

This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Enrollment: 96 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 19~50 years in healthy male volunteers
2. BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2
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: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Sequence Group 1

Experimental group

Description:

Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)

Treatment:

Drug: HIP1601

Drug: HGP1705

Sequence Group 2

Experimental group

Description:

Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)

Treatment:

Drug: HIP1601

Drug: HGP1705