A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers

Hanmi Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: HIP2503; Drug: HCP1306

Study type: Interventional

Funder types: Industry

Identifiers

NCT07297693

HM-RIZE-101

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~64 years in healthy volunteers
• 18 kg/m^2 ≤ BMI ≤ 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
• 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 14 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
• 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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60 participants in 2 patient groups

Arm 1

Experimental group

Description:

* Period1 : HCP1306 * Period2 : HIP2503

Treatment:

Drug: HCP1306

Drug: HIP2503

Arm 2

Experimental group

Description:

* Period 1 : HIP2503 * Period 2 : HCP1306

Treatment:

Drug: HCP1306

Drug: HIP2503