A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: RLD2008; Drug: HCP2001; Drug: RLD2102; Drug: RLD2007

Study type: Interventional

Funder types: Industry

Identifiers

NCT05155995

HM-DATAM-101

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.

Enrollment: 71 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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71 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001

Treatment:

Drug: RLD2102

Drug: RLD2007

Drug: HCP2001

Drug: RLD2008

Sequence 2

Experimental group

Description:

Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102

Treatment:

Drug: RLD2102

Drug: RLD2007

Drug: HCP2001

Drug: RLD2008

Sequence 3

Experimental group

Description:

Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001

Treatment:

Drug: RLD2102

Drug: RLD2007

Drug: HCP2001

Drug: RLD2008

Sequence 4

Experimental group

Description:

Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102

Treatment:

Drug: RLD2102

Drug: RLD2007

Drug: HCP2001

Drug: RLD2008