Status:

COMPLETED

A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

Lead Sponsor:

Hanmi Pharmaceutical Company Limited

Conditions:

Healthy

Eligibility:

All Genders

19-54 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Detailed Description

\[PART A\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302 \[PART B\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

Eligibility Criteria

Inclusion

  • Age 19\~54 years in healthy volunteers
  • 5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
  • Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
  • Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 3 2025

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT06518122

Start Date

September 1 2024

End Date

January 3 2025

Last Update

February 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea