Two way, two parallel groups, crossover study to compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride (new polymer) (Angelini Pharma S.p.A.) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® (Angelini Pharma S.p.A.) at steady-state in 64 Healthy Volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
64
To compare the bioavailability of 150 mg trazodone hydrochloride tablets (new polymer) vs. 150 mg trazodone hydrochloride Contramid® tablets at steady-state.
To compare the bioavailability of 300 mg trazodone hydrochloride tablets (new polymer) vs. 300 mg trazodone hydrochloride Contramid® tablets at steady-state
SocraTec R&D GmbH Clinical Pharmacology
Erfurt, Germany, Germany
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the AUC(0-Tau),ss, of trazodone.
Time frame: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the CTau, ss of trazodone.
Time frame: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the Cmax,ss of trazodone.
Time frame: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the AUC(0-Tau),ss of trazodone
Time frame: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the CTau,ss of trazodone
Time frame: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the Cmax,ss of trazodone
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Time frame: 5 days
Comparison of pharmacokinetic profiles (Concentration) of Test and Reference products
Concentration at the end of the dosing interval after the 1st, 2nd, 3rd and 4th IMP administration during treatment phase, considering scheduled times
Time frame: 5 days
Comparison of pharmacokinetic profiles (Cmin, ss) of Test and Reference products
Observed (absolute) minimum concentrations within the dosing interval Tau (profile day), considering scheduled times
Time frame: 5 days
Comparison of pharmacokinetic profiles (Fluctuation%) of Test and Reference products
Fluctuation as peak trough fluctuation, fluctuation% = {\[Cmax,ss - Cmin,ss\]/Cav} •100%
Time frame: 5 days
Comparison of pharmacokinetic profiles (Cav)of Test and Reference products
Average concentration at steady-state, Cav = AUC(0-Tau),ss/Tau
Time frame: 5 days
Comparison of pharmacokinetic profiles (Tmax, ss))of Test and Reference products
Time to reach the maximum concentration within each dosing interval (profile day), obtained directly from the data
Time frame: 5 days
Descriptive characterisation of safety of Test and Reference products
Descriptive characterisation of safety of Test and Reference products considering adverse events observed during the trial
Time frame: 8 days
Descriptive characterisation of tolerability of Test and Reference products
Descriptive characterisation of tolerability of Test and Reference products considering adverse events observed during the trial
Time frame: 8 days