Trials / Completed
CompletedNCT02783183
A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin
A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Yuhan Corporation · Industry
- Sex
- Male
- Age
- 19 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YHD1119 | 2 by 2 |
| DRUG | Lyrica | 2 by 2 |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-08-01
- Completion
- 2016-11-01
- First posted
- 2016-05-26
- Last updated
- 2019-01-16
Source: ClinicalTrials.gov record NCT02783183. Inclusion in this directory is not an endorsement.