Healthy Volunteer Clinical Trial
Official title:
A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Verified date | June 2022 |
Source | Yuhan Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 10, 2022 |
Est. primary completion date | May 10, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | Inclusion Criteria: - 19~75 years old, healthy volunteers and renal impairments - eGFR >= 60mL/min/1.73m2 - 60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2 - written informed consent Exclusion Criteria: - AST or ALT > 1.5 * Upper normal range - Total bilirubin > 1.5 * Upper normal range - Blood CPK > 1.5 * Upper normal range - Total Cholesterol >1.5 * Upper normal range - Woman who is pregnant or lactating - Patients who are difficult to participate in cinical trials judged by Investigators - have participated in other clinical trials within 180 days before IP intake |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | CHA Bundang Medical Center, CHA University | Gyeonggi-do | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yuhan Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | ||
Primary | AUClast | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | ||
Secondary | AUCinf | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | ||
Secondary | Tmax | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | ||
Secondary | t1/2 | 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour | ||
Secondary | CL/F | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | ||
Secondary | V/F | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour |
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