PHARMACOKINETIC AND BIOEQUIVALENCE COMPARISON BETWEEN EXTENDED RELEASE CAPSULES OF VENLAFAXINE HYDROCHLORIDE 150MG: AN OPEN LABEL, BALANCED, RANDOMIZED-SEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY INDIAN MALE VOLUNTEERS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 3
Abstract
This bioequivalence study was designed to determine the pharmacokinetic, bioavailability and bioequivalence of Venlafaxine HCl 150 mg Extended Release Capsules in comparison with Effexor®-XR 150mg Extended Release Capsules after single dose administration under fed conditions in 20 healthy adult male subjects. Therefore the design of an open label, balanced, randomized, two-sequence, single dose, two way crossover study with a washout period of at least 7 days was used. Each volunteer received a 150 mg capsule of the reference or test drug respectively. On the day of dosing, blood samples were collected before dosing and at various time points up to 72 hours after dosing. Analysis of venlafaxine and its metabolite O-Desmethylvenlafaxine concentrations was performed using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (Cmax, AUC0-t and AUC0-inf) 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The geometric mean ratios (Test/Reference) between the two products of extended-release venlafaxine capsule under fed condition were 104.91% (92.86%-118.53%) and 114.41% (103.43%-124.55%) for Cmax ratios, 102.24% (95.95%-108.94%) and 105.27% (96.76%-114.53%) for AUC0-t ratios and 101.66% (95.73%-107.97%) and 104.71% (96.13%-114.05%) for AUC0-inf ratios of Venlafaxine and its metabolite O-Desmethylvenlafaxine (ODV) respectively. 20 volunteers had completed both treatment periods. There was no significant difference of the Tmax parameter between the two formulations (p >0.05). No serious adverse events related to the study drugs were found. This single dose study found that the test formulation Venlafaxine HCl Extended release capsules is bioequivalent to the reference formulation Effexor®-XR Extended Release Capsules the extent and the rate of absorption, of 150mg under fed condition in healthy adult male volunteers according to the USFDA regulatory guidance.
Authors and Affiliations
I. Sarath chandiran, Jayaveera K. N. , Raghunadha Reddy
Keywords
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