Trials / Completed
CompletedNCT05012436
A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Yuhan Corporation · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YHD1119 75mg | A single oral dose |
Timeline
- Start date
- 2021-07-24
- Primary completion
- 2022-05-10
- Completion
- 2022-05-10
- First posted
- 2021-08-19
- Last updated
- 2022-06-30
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05012436. Inclusion in this directory is not an endorsement.