Skip to main content
OpenTrials
Completed

NCT Number: NCT05723549

A Study to Evaluate the PK, Safety and Tolerability of HCP1803.

A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19~45 years in healthy male volunteers
  • Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
  • Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm.
  • 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

  • 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
  • Subjects who judged ineligible by the investigator

Treatment and study plan

HCP1803-3

Drug

Take it once per period

RLD2002

Drug

Take it once per period

HCP1904-1

Drug

Take it once per period

Primary outcomes

  1. Cmax

    Time frame: 0~144hours

    pharmacokinetic evaluation

  2. AUC last

    Time frame: 0~144hours

    pharmacokinetic evaluation

Secondary outcomes

  1. AUC inf

    Time frame: 0~144hours

    pharmacokinetic evaluation

  2. Tmax

    Time frame: 0~144hours

    pharmacokinetic evaluation

  3. t1/2

    Time frame: 0~144hours

    pharmacokinetic evaluation

  4. CL/F

    Time frame: 0~144hours

    pharmacokinetic evaluation

  5. Vd/F

    Time frame: 0~144hours

    pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.