An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HGP1910
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- AUClast of Rosuvastatin
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 19\~45 years in healthy volunteers
- •BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
- •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
- •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 1
Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903
Intervention: HGP1910
Sequence 1
Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903
Intervention: HGP1909
Sequence 1
Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903
Intervention: HCP1903
Sequence 2
Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909
Intervention: HGP1910
Sequence 2
Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909
Intervention: HGP1909
Sequence 2
Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909
Intervention: HCP1903
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Cmax of Total Ezetimibe(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)
- AUClast of Total Ezetimibe(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)
- AUCinf of Rosuvastatin(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)
- Tmax of Rosuvastatin(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)
- t1/2 of Rosuvastatin(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)
- CL/F of Rosuvastatin(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)
- Vd/F of Rosuvastatin(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)
- AUCinf of Free Ezetimibe(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)
- Tmax of Free Ezetimibe(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)
- t1/2 of Free Ezetimibe(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)
- CL/F of Free Ezetimibe(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)
- Vd/F of Free Ezetimibe(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)
- AUCinf of Total Ezetimibe(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)
- Tmax of Total Ezetimibe(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)
- t1/2 of Total Ezetimibe(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)
- CL/F of Total Ezetimibe(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)
- Vd/F of Total Ezetimibe(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)