Journal article
Bioequivalence Studies of a Reformulated Dutasteride and Tamsulosin Hydrochloride Combination Capsule and a Commercially Available Formulation
Clinical pharmacology in drug development, v 6(5), pp 508-516
Sep 2017
PMID: 28127948
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
A dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg combination (DTC) capsule (Duodart
) was reformulated to reduce the capsule size and enhance product stability. Bioequivalence of the reformulated DTC capsule with the commercial formulation was evaluated in 2 single-dose, open-label, randomized, 2-way crossover studies in healthy adult male volunteers. Subjects in a fasted or fed state received a single oral dose of either the reformulated DTC or the commercial formulation followed by a 28-day washout period between treatments. Blood samples were taken predose and up to 72 hours postdose for pharmacokinetic (PK) analysis of dutasteride and tamsulosin serum concentrations. From the serum concentration-vs-time data, a noncompartmental method was used to calculate the maximum observed serum concentration (C
) and area under the serum concentration-time curve (AUC
) for dutasteride and tamsulosin, and AUC
for tamsulosin. The 90% confidence intervals for the ratios of the C
and AUC
(for dutasteride and tamsulosin) and for AUC
(for tamsulosin) were all completely contained within the range of 80% to 125%; therefore, the reformulated DTC capsule is bioequivalent to the commercial formulation under both fed and fasted states.
Metrics
Details
- Title
- Bioequivalence Studies of a Reformulated Dutasteride and Tamsulosin Hydrochloride Combination Capsule and a Commercially Available Formulation
- Creators
- Renee Kurczewski - Providence CollegeChet Bowen - GlaxoSmithKlineDavid Collins - Parexel International, Durham, North Carolina.John Zhu - GlaxoSmithKlineGulyeter Serbest - Incyte (United States)Michael Manyak - GlaxoSmithKline
- Publication Details
- Clinical pharmacology in drug development, v 6(5), pp 508-516
- Publisher
- Wiley
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems
- Web of Science ID
- WOS:000409336100010
- Scopus ID
- 2-s2.0-85011534528
- Other Identifier
- 991019176799204721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Pharmacology & Pharmacy