Complete dataset for 2-treatment, 2-sequence, 2-period efavirenz bioequivalence study conducted with nightly dosing
Manuel Ibarra,
Laura Magallanes,
Marianela Lorier,
Marta Vázquez,
Pietro Fagiolino
Affiliations
Manuel Ibarra
Bioavailability and Bioequivalence Centre for Medicine Evaluation (CEBIOBE) – Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay
Laura Magallanes
Bioavailability and Bioequivalence Centre for Medicine Evaluation (CEBIOBE) – Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay
Marianela Lorier
Bioavailability and Bioequivalence Centre for Medicine Evaluation (CEBIOBE) – Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay
Marta Vázquez
Bioavailability and Bioequivalence Centre for Medicine Evaluation (CEBIOBE) – Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay
Pietro Fagiolino
Corresponding author.; Bioavailability and Bioequivalence Centre for Medicine Evaluation (CEBIOBE) – Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay
The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013). Dose was administered at night (9:00 p.m.) two hours after food intake. Fourteen healthy subjects, 8 women and 6 men, completed the study. For each subject, 15 data points until 96 h post-administration are included. Subject demographic characteristics and sequences of administration are provided along with individual pharmacokinetic profiles of efavirenz obtained for both formulations after a single oral dose of 600 mg. This data provides information in support of the research article “Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets” [1]. Keywords: Efavirenz, Bioequivalence
