Trial reportClinical drug investigation2012
Relative bioavailability study of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy male fasted volunteers.
Trial report in Clinical drug investigation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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0 citing papers in PubMed, 7 citations in OpenAlex.
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveTenofovir dipivoxil fumarate (9-[(R)-2-[[bis (pivaloyloxymethoxy) phosphinoyl] methoxy] propyl] adenine fumarate) is a novel ester prodrug of tenofovir. It has been developed as an anti-hepatitis B virus clinical candidate. The purpose of this study was to determine the pharmacokinetic parameters of tenofovir dipivoxil fumarate (test) and the commercially available tenofovir disoproxil fumarate (Viread®, reference). In addition, the bioavailability of tenofovir dipivoxil fumarate was evaluated in healthy male fasted subjects after a single comparatively equivalent dose.
methodsThis single-dose, randomized, two-way, open-label, crossover study was conducted at Xijing Hospital, Xi'an, China. The study drug was administered under fasted conditions. Serial blood samples were obtained over 72 hours after oral administration of each treatment. Bioavailability of the drug was assessed in accordance with the State Food and Drug Administration bioequivalence criteria.
resultsEighteen subjects were enrolled and completed the study, with all study treatments being generally well tolerated. The geometric mean ratios (90% confidence interval [CI]) for maximum plasma concentration (C(max)), area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(last)), and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(∞)) were 124.49% (90% CI 115.85, 133.79), 122.85% (90% CI 115.55, 130.62), and 122.43% (90% CI 115.71, 129.54), respectively.
conclusionThe relative bioavailability of tenofovir dipivoxil was 20% higher compared with tenofovir disoproxil fumarate; this result was consistent with the preclinical data.
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