A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: RLD2301; Drug: RLD2007

Study type: Interventional

Funder types: Industry

Identifiers

NCT05862090

HM-ENSEMBLE-101

Details and patient eligibility

About

The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.

Enrollment: 40 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
• 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: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Arm 1 (First RLD2301, then RLD2301+RLD2007)

Experimental group

Description:

Period1 : RLD2301 Period2 : RLD2301 + RLD2007

Treatment:

Drug: RLD2301

Drug: RLD2007

Arm 2 (First RLD2007, then RLD2301+RLD2007)

Experimental group

Description:

Period1 : RLD2007 Period2 : RLD2301 + RLD2007

Treatment:

Drug: RLD2301

Drug: RLD2007