Dustri Online Services

Search Results

Books: 0	Journals: 1	Articles: 1

Bioavailability Section

Comparative pharmacokinetics and bioequivalence of two tablet formulations of 2 mg risperidone in healthy Thai male volunteers

N. Khorana, S. Maphanta, O. Lohitnavy, A. Srichaiya and J. Sayasathid

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 49 p. 409 - 414

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 49 – No. 6/2011 (409-414)

Comparative pharmacokinetics and bioequivalence of two tablet formulations of 2 mg risperidone in healthy Thai male volunteers

N. Khorana¹,², S. Maphanta¹,³, O. Lohitnavy¹,³, A. Srichaiya¹ and J. Sayasathid⁴

¹Bioequivalence Test Center, ²Department of Pharmaceutical Chemistry and Pharmacognosy, ³Department of Pharmaceutical Practice, Faculty of Pharmaceutical Sciences, ⁴Naresuan University Hospital, Naresuan University, Phitsanulok, Thailand
Background: Risperidone is an atypical antipsychotic drug with potent serotonin and moderate dopamine antagonistic properties. It possesses good bioavailability following oral administration. Risperidone is primarily converted by the cytochrome P450 2D6 (CYP2D6) and 3A4 (CYP3A4) enzymes to 9-hydroxyrisperidone, its active metabolite with equivalent potency to the parent compound. Objective: This study aimed to compare the pharmacokinetics and determine bioequivalence of two risperidone immediate release oral tablets, a test formulation (Risperidone GPO^® or “Test”) and a reference formulation (Risperdal^® or “Reference”). Method: A single-dose, randomized, fasting, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in 23 healthy Thai male volunteers. Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 h following an oral administration of 2 mg risperidone. The plasma concentrations of risperidone and 9-hydroxyrisperidone were determined by using a validated HPLC method. Pharmacokinetic parameters of Test and Reference were obtained by noncompartmental analysis. Results: The 90% confidence intervals for Test/Reference ratios of the pharmacokinetic parameters (C_max, AUC_0–t and AUC_0–∞) of both risperidone and its active metabolite (9-hydroxyrisperidone) fell within the acceptable bioequivalence range (80 – 125%) according to ASEAN guideline. Conclusion: The two risperidone formulations are bioequivalent. The test formulation may be used for generic substitution where applicable.Correspondence to:
N. Khorana
Department of Pharmaceutical Chemistry and Pharmacognosy
Faculty of Pharmaceutical Sciences
Naresuan University
Phitsanulok, Thailand 65000
Email: [email protected]

Shopping Overview

Shopping Overview
Type	Qtty	Discount	VAT	Price
Your basket is empty

View Cart

Search Results

Shopping Overview

Send us an E-Mail