Trials / Completed
CompletedNCT01082250
The Bioequivalence Of Two Different Lurasidone Formulations In Patients
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Detailed description
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurasidone HCl | 120mg dose. 3-way cross-over for 21 days |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2010-03-08
- Last updated
- 2011-09-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01082250. Inclusion in this directory is not an endorsement.