A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903

Overview

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

Full Title of Study: “An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903 in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 26, 2021

Interventions

  • Drug: HGP1910
    • Take it once per period.
  • Drug: HGP1909
    • Take it once per period.
  • Drug: HCP1903
    • Take it once per period.

Arms, Groups and Cohorts

  • Experimental: Sequence 1
    • Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903
  • Experimental: Sequence 2
    • Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUClast of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Cmax of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUClast of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation

Secondary Measures

  • Cmax of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUClast of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUCinf of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Tmax of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • t1/2 of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • CL/F of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Vd/F of Rosuvastatin
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUCinf of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Tmax of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • t1/2 of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • CL/F of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Vd/F of Free Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • AUCinf of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Tmax of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • t1/2 of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • CL/F of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation
  • Vd/F of Total Ezetimibe
    • Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    • pharmacokinetic evaluation

Participating in This Clinical Trial

Inclusion Criteria

1. Age 19~45 years in healthy volunteers 2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2 3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria:

1. 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 2. Subjects who judged ineligible by the investigator

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hanmi Pharmaceutical Company Limited
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.