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A Randomized, Four-way Crossover Pilot Study to Compare the Relative Bioavailability of Two Prototype Once-a-day Trazodone Hydrochloride Products and Two Marketed Reference Products Following an Equivalent Daily Dose Administration Under Fasting Conditions in Healthy Volunteers
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.
Details
| Lead sponsor | Labopharm Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2005-03 |
Conditions
- Healthy
Interventions
- Trazodone HCl
- Trazodone HCl
- Trazodone HCl
- Trazodone HCl
Primary outcomes
- Bioequivalence Based on AUC(0-t) — 72 hours
AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration. Measured in nanogram x hours per milliliter (ng\*h/mL). - Bioequivalence Based on AUC(0-∞) — 72 hours
AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞). Measured in nanogram x hours per milliliter (ng\*h/mL). - Bioequivalence Based on Cmax — 72 hours
Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).