A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: RLD2008; Drug: RLD2007; Drug: HCP1902

Study type: Interventional

Funder types: Industry

Identifiers

NCT04946903

HM-DATA-101

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers

Enrollment: 33 patients

Sex: All

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19~54 years in healthy volunteers 19 kg/m^2 ≤ BMI < 28 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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33 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902

Treatment:

Drug: RLD2007

Drug: HCP1902

Drug: RLD2008

Sequence 2

Experimental group

Description:

Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008

Treatment:

Drug: RLD2007

Drug: HCP1902

Drug: RLD2008