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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1306; Drug: RLD2302; Drug: RLD2102

• Registration Number: NCT06518122
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2024-09-01
• Primary Completion: 2025-01-03
• Study Completion: 2025-01-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Age 19~54 years in healthy volunteers
• 18.5 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
[PART A] Sequence 1	HCP1306	Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 1	RLD2302	Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 2	HCP1306	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
[PART A] Sequence 2	RLD2302	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
[PART A] Sequence 3	HCP1306	Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
[PART A] Sequence 3	RLD2302	Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
[PART A] Sequence 4	RLD2302	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
[PART A] Sequence 5	HCP1306	Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 5	RLD2302	Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 6	RLD2302	Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
[PART B] Single arm	HCP1306	Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
[PART B] Single arm	RLD2102	Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
[PART A] Sequence 6	HCP1306	Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
[PART A] Sequence 4	HCP1306	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
[PART B] Single arm	RLD2302	Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)

Primary Outcome Measures

Name	Time	Method
AUCtau	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Css,max	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
Fluctuation[(Css,max-Css,min)/Css,av]	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Css,min	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Css,av	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Tss,max	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
t1/2	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
CLss/F	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Vdss/F	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation
Swing[(Css,max-Css,min)/Css,min]	[PART A] 0~72 hours, [PART B] 0~48hours after final dose administration	Pharmacokinetic evaluation

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of