NDLI: Bioequivalence study of 8 mg ondansetron film-coated tablets in healthy Caucasian volunteers.

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Bioequivalence study of 8 mg ondansetron film-coated tablets in healthy Caucasian volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Rudzki, P. J. Kaza, M. Les, A. Gilant, E. Ksycinska, H. Serafin-Byczak, K. Troc, M. Raszek, J. Piatkowska-Chabuda, E. Skowronska-Smolak, M. Tarasiuk, A. Wilkowska, E. Lazowski, T.
Description	Country affiliation: Poland Author Affiliation: Rudzki PJ ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Kaza M ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Les A ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Gilant E ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Ksycinska H ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Serafin-Byczak K ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Troc M ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Raszek J ( Clinical Centre CRO Poland Sp. z o. o., Otwock, Poland.); Piatkowska-Chabuda E ( Tarchominskie Zaklady Farmaceutyczne Polfa S.A., Warsaw, Poland.); Skowronska-Smolak M ( Tarchominskie Zaklady Farmaceutyczne Polfa S.A., Warsaw, Poland.); Tarasiuk A ( Tarchominskie Zaklady Farmaceutyczne Polfa S.A., Warsaw, Poland.); Wilkowska E ( Pharmacology Department, Pharmaceutical Research Institute, Warsaw, Poland.); Lazowski T ( Clinical Centre CRO Poland Sp. z o. o., Otwock, Poland.)
Abstract	The aim of the study was to investigate the bioequivalence of a generic product of 8 mg film-coated tablets (test) to the branded product (reference) at the same strength in order to apply for regulatory approval. The secondary objective of the study was to compare the tolerability of both products. A double blinded, randomized, cross-over, 2-period, comparative study was conducted in healthy Caucasian volunteers under fasting conditions. A single oral dose administration of the test or reference product was followed by a 7-day wash-out period. The ondansetron concentration was determined using a validated high performance liquid chromatography with a UV detection method. The 90% confidence interval of the point estimate (test over reference products) for C(max) and AUC(0-t) fell within the 80.00-125.00% acceptance range. The results of the study indicate that the film-coated tablets of Ondatron 8 mg manufactured by Tarchominskie Zaklady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zofran manufactured by GlaxoSmithKline Export Ltd (reference product). Both products were well tolerated.
File Format	HTM / HTML
ISSN	21949379
Issue Number	4
Volume Number	64
e-ISSN	21949387
Journal	Drug Research
Language	English
Publisher	Thieme
Publisher Date	2014-04-01
Publisher Place	Germany
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Ondansetron Pharmacokinetics Adolescent Adult Cross-over Studies Double-blind Method Female Healthy Volunteers Humans Male Middle Aged Adverse Effects Tablets Therapeutic Equivalency Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine Drug Discovery

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