A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1801; Drug: HCP1805

Study type: Interventional

Funder types: Industry

Identifiers

NCT03826641

HM-DAME-101

Details and patient eligibility

About

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.

Enrollment: 85 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 19~45 years in healthy 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)

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85 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801

Treatment:

Drug: HCP1801

Drug: HCP1805

Sequence 2

Experimental group

Description:

Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805

Treatment:

Drug: HCP1801

Drug: HCP1805

Sequence 3

Experimental group

Description:

Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801

Treatment:

Drug: HCP1801

Drug: HCP1805

Sequence 4

Experimental group

Description:

Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805

Treatment:

Drug: HCP1801

Drug: HCP1805