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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RLD2007; Drug: RLD2008; Drug: HCP1902

• Registration Number: NCT04946903
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	RLD2007	Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902
Sequence 2	HCP1902	Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008
Sequence 1	RLD2008	Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902
Sequence 2	RLD2008	Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008
Sequence 1	HCP1902	Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902
Sequence 2	RLD2007	Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008

Primary Outcome Measures

Name	Time	Method
Cmax	0~48 hour	Pharmacokinetic evaluation
AUCt	0~48 hour	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
t1/2	0~48 hour	Pharmacokinetic evaluation
AUCinf	0~48 hour	Pharmacokinetic evaluation
Tmax	0~48 hour	Pharmacokinetic evaluation
CL/F	0~48 hour	Pharmacokinetic evaluation
Vd/F	0~48 hour	Pharmacokinetic evaluation

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of