A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers
- Registration Number
- NCT05155995
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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 3 RLD2007 Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001 Sequence 3 RLD2008 Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001 Sequence 1 HCP2001 Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001 Sequence 2 RLD2007 Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102 Sequence 3 RLD2102 Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001 Sequence 4 RLD2008 Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102 Sequence 1 RLD2007 Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001 Sequence 1 RLD2008 Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001 Sequence 2 RLD2008 Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102 Sequence 3 HCP2001 Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001 Sequence 4 HCP2001 Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102 Sequence 1 RLD2102 Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001 Sequence 2 HCP2001 Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102 Sequence 4 RLD2007 Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102 Sequence 4 RLD2102 Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102 Sequence 2 RLD2102 Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
- Primary Outcome Measures
Name Time Method AUCt 0~48hr Pharmacokinetic evaluation
Cmax 0~48hr Pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method t1/2 0~48hr Pharmacokinetic evaluation
CL/F 0~48hr Pharmacokinetic evaluation
Vd/F 0~48hr Pharmacokinetic evaluation
AUCinf 0~48hr Pharmacokinetic evaluation
Tmax 0~48hr Pharmacokinetic evaluation
Trial Locations
- Locations (1)
Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of