A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HGP1910; Drug: HGP1909; Drug: HCP1903

Study type: Interventional

Funder types: Industry

Identifiers

NCT04762407

HM-ROZE-103

Details and patient eligibility

About

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

Enrollment: 57 patients

Sex: Male

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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57 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903

Treatment:

Drug: HGP1909

Drug: HCP1903

Drug: HGP1910

Sequence 2

Experimental group

Description:

Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909

Treatment:

Drug: HGP1909

Drug: HCP1903

Drug: HGP1910