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NCT04762407 Clinical Trial

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

Healthy Clinical Trial

Official title:
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04762407
Other study ID # HM-ROZE-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 20, 2020
Est. completion date February 24, 2021

Study information
Verified date July 2022
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date February 24, 2021
Est. primary completion date February 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax of Rosuvastatin pharmacokinetic evaluation 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
Primary AUClast of Rosuvastatin pharmacokinetic evaluation 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
Primary Cmax of Free Ezetimibe pharmacokinetic evaluation 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
Primary AUClast of Free Ezetimibe pharmacokinetic evaluation 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
Secondary Cmax of Total Ezetimibe pharmacokinetic evaluation 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
Secondary AUClast of Total Ezetimibe pharmacokinetic evaluation 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
Secondary AUCinf of Rosuvastatin pharmacokinetic evaluation 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
Secondary Tmax of Rosuvastatin pharmacokinetic evaluation 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
Secondary t1/2 of Rosuvastatin pharmacokinetic evaluation 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
Secondary CL/F of Rosuvastatin pharmacokinetic evaluation 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
Secondary Vd/F of Rosuvastatin pharmacokinetic evaluation 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
Secondary AUCinf of Free Ezetimibe pharmacokinetic evaluation 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
Secondary Tmax of Free Ezetimibe pharmacokinetic evaluation 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
Secondary t1/2 of Free Ezetimibe pharmacokinetic evaluation 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
Secondary CL/F of Free Ezetimibe pharmacokinetic evaluation 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
Secondary Vd/F of Free Ezetimibe pharmacokinetic evaluation 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
Secondary AUCinf of Total Ezetimibe pharmacokinetic evaluation 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
Secondary Tmax of Total Ezetimibe pharmacokinetic evaluation 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
Secondary t1/2 of Total Ezetimibe pharmacokinetic evaluation 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
Secondary CL/F of Total Ezetimibe pharmacokinetic evaluation 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
Secondary Vd/F of Total Ezetimibe pharmacokinetic evaluation 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
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