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Clinical Trials/NCT04946903
NCT04946903CompletedPhase 1

A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HCP1902 and RLD2007/RLD2008 in Healthy Volunteers

Hanmi Pharmaceutical Company Limited1 site in 1 country33 target enrollmentStarted: June 10, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
Cmax

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 54 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Sequence 2

Experimental

Period 1: Fasted state + HCP1902,

Period 2: Fasted state + RLD2007 + RLD2008

Intervention: HCP1902 (Drug)

Sequence 1

Experimental

Period 1: Fasted state + RLD2007 +RLD2008,

Period 2: Fasted state + HCP1902

Intervention: RLD2007 (Drug)

Sequence 1

Experimental

Period 1: Fasted state + RLD2007 +RLD2008,

Period 2: Fasted state + HCP1902

Intervention: RLD2008 (Drug)

Sequence 1

Experimental

Period 1: Fasted state + RLD2007 +RLD2008,

Period 2: Fasted state + HCP1902

Intervention: HCP1902 (Drug)

Sequence 2

Experimental

Period 1: Fasted state + HCP1902,

Period 2: Fasted state + RLD2007 + RLD2008

Intervention: RLD2007 (Drug)

Sequence 2

Experimental

Period 1: Fasted state + HCP1902,

Period 2: Fasted state + RLD2007 + RLD2008

Intervention: RLD2008 (Drug)

Outcomes

Primary Outcomes

Cmax

Time Frame: 0~48 hour

Pharmacokinetic evaluation

AUCt

Time Frame: 0~48 hour

Pharmacokinetic evaluation

Secondary Outcomes

  • AUCinf(0~48 hour)
  • t1/2(0~48 hour)
  • Tmax(0~48 hour)
  • CL/F(0~48 hour)
  • Vd/F(0~48 hour)

Investigators

Sponsor
Hanmi Pharmaceutical Company Limited
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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