A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2022-07-25

Brief Summary

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A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group1

Period1: HCP1904-1

Group Type EXPERIMENTAL

HCP1904-1

Intervention Type DRUG

take it once per period

group2

Period1: HCP1904-3

Group Type EXPERIMENTAL

HCP1904-3

Intervention Type DRUG

take it once per period

Interventions

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HCP1904-1

take it once per period

Intervention Type DRUG

HCP1904-3

take it once per period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 19\~45 years in healthy male volunteers
2. Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to 14 days 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes