A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HIP1801; Drug: HIP1402

Study type: Interventional

Funder types: Industry

Identifiers

NCT04084197

HM-TOD-101

Details and patient eligibility

About

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.

Enrollment: 61 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 19~45 years in healthy male volunteers
2. BMI is more than 18.5 kg/m^2 , no more than 29.9 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: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

61 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801

Treatment:

Drug: HIP1801

Drug: HIP1402

Sequence 2

Experimental group

Description:

Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402

Treatment:

Drug: HIP1801

Drug: HIP1402

Sequence 3

Experimental group

Description:

High fat diet + HIP1402, Period 2 : High fat diet + HIP1801

Treatment:

Drug: HIP1801

Drug: HIP1402

Sequence 4

Experimental group

Description:

High fat diet + HIP1801, Period 2 : High fat diet + HIP1402

Treatment:

Drug: HIP1801

Drug: HIP1402