A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP2201; Drug: RLD2206; Drug: RLD2205

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737082

HM-PRADA-101

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.

Enrollment: 44 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~55 years in healthy male volunteers
• 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight ≥55kg
• 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 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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44 participants in 2 patient groups

Sequence 1

Experimental group

Description:

* Period 1, Period 3: RLD2205 + RLD2206 * Period 2, Period 4: HCP2201

Treatment:

Drug: RLD2205

Drug: HCP2201

Drug: RLD2206

Sequence 2

Experimental group

Description:

* Period 1, Period 3: HCP2201 * Period 2, Period 4: RLD2205 + RLD2206

Treatment:

Drug: RLD2205

Drug: HCP2201

Drug: RLD2206