A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1701; Drug: HGP0608; Drug: HGP0904; Drug: HCP1306

Study type: Interventional

Funder types: Industry

Identifiers

NCT04322266

HM-AMOS-102

Details and patient eligibility

About

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets 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 volunteers
2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. 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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61 participants in 2 patient groups

Sequence 1 (Reference-Test)

Experimental group

Description:

Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701

Treatment:

Drug: HCP1306

Drug: HGP0904

Drug: HGP0608

Drug: HCP1701

Sequence 2 (Test-Reference)

Experimental group

Description:

Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608

Treatment:

Drug: HCP1306

Drug: HGP0904

Drug: HGP0608

Drug: HCP1701