A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State
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|ClinicalTrials.gov Identifier: NCT01121926|
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : August 16, 2010
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects Bioavailability Pharmacokinetics||Drug: Trazodone HCl||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered Once Daily) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) at Steady State|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Experimental: Trazodone HCl OAD
OAD: Once A Day
Drug: Trazodone HCl
Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).
75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours.
Other Name: Oleptro
|Active Comparator: Trazodone HCl (Apotex Corp.)||
Drug: Trazodone HCl
Immediate-release tablet containing 100 mg trazodone HCl
100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours.
- Bioequivalence Based on Cmax,ss [ Time Frame: 9 days ]Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).
- Bioequivalence Based on AUCss [ Time Frame: 9 days ]
AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss.
Measured in nanograms x hours per milliliter (ng*h/mL).
- Minimum Plasma Concentration (Cmin,ss) [ Time Frame: 9 days ]Minimum plasma concentration at steady state (Cmin,ss). Measured in nanograms per milliliter (ng/mL)
- Plasma Concentration at 24 Hours Post-evening Dose (C24h) [ Time Frame: 9 days ]Plasma concentration at 24 hours post-evening dose (C24h) in nanograms per milliliter (ng/mL)
- Time to Peak Exposure (Tmax) [ Time Frame: 9 days ]Time to peak exposure (Tmax) at steady state.
- Percentage Swing [ Time Frame: 9 days ]
Percentage swing is a pharmacokinetic parameter calculated as follows:
((Cmax,ss - Cmin,ss)/Cmin,ss)*100.
Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.
It was calculated over 24 hours on day 9.
- Percentage Peak-Trough Fluctuation (%PTF) [ Time Frame: 9 days ]
Percentage Peak-Trough Fluctuation (%PTF) of trazodone calculated as [100*(Cmax-Cmin)/Cav].
Cmax: Maximum plasma concentration Cmin: Minimum plasma concentration Cav: Average plasma concentration