A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- AUCt
Study Overview
Brief Summary
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.
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 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
Intervention: HCP2001 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
Intervention: RLD2007 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
Intervention: HCP2001 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
Intervention: RLD2007 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
Intervention: RLD2008 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
Intervention: RLD2102 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
Intervention: HCP2001 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2007 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2008 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2102 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
Intervention: RLD2008 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
Intervention: RLD2102 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
Intervention: HCP2001 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2007 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2008 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
Intervention: RLD2102 (Drug)
Outcomes
Primary Outcomes
AUCt
Time Frame: 0~48hr
Pharmacokinetic evaluation
Cmax
Time Frame: 0~48hr
Pharmacokinetic evaluation
Secondary Outcomes
- t1/2(0~48hr)
- CL/F(0~48hr)
- Vd/F(0~48hr)
- AUCinf(0~48hr)
- Tmax(0~48hr)