Source:http://linkedlifedata.com/resource/pubmed/id/18751504
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
7
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pubmed:dateCreated |
2008-8-28
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pubmed:abstractText |
The bioavailability of a new terbinafine (CAS 91161-71-6) preparation was compared with a commercially available original preparation (reference) of the drug in 19 Chinese healthy male volunteers. The study was performed in an open, randomized, single blind two-sequence, two-period crossover design. Under fasting conditions, each subject received a single oral dose of 250 mg terbinafine as a test or reference formulation with a 7-day washout period between the two preparations. The plasma concentrations of terbinafine were analyzed by a sensitive liquid chromatography-ultraviolet spectrometry method. The pharmacokinetic parameters included AUC(0-t) AUC(0-infinity), C(max), t1/2, and T(max). The values of AUC(0-t) demonstrated nearly identical bioavailability of terbinafine from the examined formulations. The AUC(0.48) of terbinafine was 5982.85 +/- 2449.17 and 6761.63 +/- 3140.33 ng x h/ml for the test and reference formulation, respectively. The maximum plasma concentration (C(max)) of terbinafine was 1656.25 +/- 623.18 ng/ml for the test and 1552.07 +/- 660.35 ng/ml for the reference product, respectively. No statistical differences were observed for C(max) and the area under the plasma concentration time curve for terbinafine. The 90% confidence limits calculated for C(max) and AUC from zero to infinity (AUC(0-infinity)) of terbinafine were within the bioequivalence range (80%-125% for AUC). This study shows that the test formulation is bioequivalent to the reference formulation of terbinafine.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:issn |
0004-4172
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
58
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
363-6
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pubmed:meshHeading |
pubmed-meshheading:18751504-Adult,
pubmed-meshheading:18751504-Antifungal Agents,
pubmed-meshheading:18751504-Area Under Curve,
pubmed-meshheading:18751504-Biological Availability,
pubmed-meshheading:18751504-Chemistry, Pharmaceutical,
pubmed-meshheading:18751504-Chromatography, High Pressure Liquid,
pubmed-meshheading:18751504-Cross-Over Studies,
pubmed-meshheading:18751504-Double-Blind Method,
pubmed-meshheading:18751504-Humans,
pubmed-meshheading:18751504-Male,
pubmed-meshheading:18751504-Naphthalenes,
pubmed-meshheading:18751504-Spectrophotometry, Ultraviolet,
pubmed-meshheading:18751504-Tablets
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pubmed:year |
2008
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pubmed:articleTitle |
Pharmacokinetics and comparative bioavailability of two terbinafine hydrochloride formulations after single-dose administration in Chinese healthy subjects.
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pubmed:affiliation |
Laboratory of Physical and Chemical Analysis, JiangSu Centers for Diseases Prevention and Control, Nanjing, PR China.
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pubmed:publicationType |
Journal Article,
Comparative Study,
Randomized Controlled Trial
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