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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1306; Drug: RLD2102; Drug: RLD2302

Study type: Interventional

Funder types: Industry

Identifiers

NCT06518122

HM-ROEM-101

Details and patient eligibility

About

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

Full 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

Enrollment: 66 patients

Sex: All

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 7 patient groups

[PART A] Sequence 1

Experimental group

Description:

Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART A] Sequence 2

Experimental group

Description:

Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART A] Sequence 3

Experimental group

Description:

Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART A] Sequence 4

Experimental group

Description:

Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART A] Sequence 5

Experimental group

Description:

Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART A] Sequence 6

Experimental group

Description:

Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)

Treatment:

Drug: RLD2302

Drug: HCP1306

[PART B] Single arm

Experimental group

Description:

Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)

Treatment:

Drug: RLD2102

Drug: RLD2302

Drug: HCP1306