Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1305; Drug: HCP0605 + HGP0816

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039724

HM-ALRO-102

Details and patient eligibility

About

To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Full description

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Enrollment: 61 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteer, age 19~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric 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 A

Experimental group

Description:

Period 1 : HCP0605+HGP0816 Period 2 : HCP1305

Treatment:

Drug: HCP1305

Drug: HCP0605 + HGP0816

Sequence B

Experimental group

Description:

Period 1 : HCP1305 Period 2 : HCP0605+HGP0816

Treatment:

Drug: HCP1305

Drug: HCP0605 + HGP0816