NCT01082289CompletedPhase 1
A Phase 1, Open-Label, Drug-Drug Interaction Study to Determine the Effect of Repeated Dose Lurasidone 120 mg Administration on the Pharmacokinetics of Orally Administered Digoxin 0.25 mg in Patients With Schizophrenia or Schizoaffective Disorder.
Sumitomo Pharma America, Inc.2 sites in 1 country24 target enrollmentStarted: September 1, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
Study Overview
Brief Summary
The objective of this study is to evaluate the pharmacokinetic profile of digoxin when administered alone and when administered with repeated dose of lurasidone 120mg.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female 18 to 65 years of age
- •BMI >= 19.5 and <= 37 kg/m2
- •No clinically relevant abnormal laboratory values
Exclusion Criteria
- •History or presence of renal or hepatic insufficiency
- •Participated in a clinical trial in the past 30 days
- •Use of con meds that prolong the QT/QTc taken within 28 days prior to study drug administration
Investigators
Study Sites (2)
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