drugset / Trial / NCT01121913
Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
The objectives of this study were: * to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition; * to assess the controlled release properties of the two prototype formulations; * to select a prototype formulation for further development; * to validate the blood sampling schedule for future pivotal pharmacokinetic studies; * to determine the appropriate sample size for pivotal studies based in the intra-subject variability.
Timeline
- Start
- 2005-03
- Primary completion
- 2005-04
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Trazodone | Small molecule | 100 mg | Oral |
| Comparator | Trazodone | Small molecule | 150 mg | Oral |
| Comparator | Trazodone | Small molecule | 300 mg | Oral |
Indications
No indication recorded.