A Randomized Phase I Bioequivalence Clinical Trial of a Paediatric Fixed-Dose Combination Antiretroviral Reconstitutable Suspension in Healthy Adult Volunteers

Abstract

This single dose randomized study found that the test and reference products met the criteria for bioequivalence in the fasting healthy adult volunteers.

Pooled bioequivalence study database from Turkey: characterization of adverse events and determination of split points based on Gini Index as a promising method

“…Although the BE studies are widely being conducted all over the world, a research on overall adverse event specific evaluations were not found. Research on the adverse reactions as a post-marketing safety survelliance often takes place in the scientific literature (Lazarou et al 1998 ; Sibille et al 1998 ; Baker et al 2004 ) while BE studies were mostly focused on the pharmacokinetics, assessing the relationship between genetic polymorphisms, and safety issues of the single test (generic) and reference (originator) drugs (Zhang et al 2006 ; Zhang et al 2007 ; Cho et al 2009 ; Esseku et al 2013 ; Gao et al 2015 ; Mak et al 2015 ). Therefore, our study has the originality by revisiting the BE studies of 13 years period belonging to one of the CRO’s database (N-CRO) in Turkey, regarding the frequency, type, drug subgroups, cut off (split points using Gini Index) values and probable causes of adverse events.…”

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Zidovudine (Azidothymidine)

“…The clinical batch of the test product was manufactured by Emerson Resources Inc. (Norristown, Pennsylvania) Xylitol, sucralose, microcrystalline cellulose, carboxymethylcellulose sodium, colloidal silicon dioxide, methylparaben, and propylparaben were used as excipients. The 90% CI for the geometric mean ratio of test/reference for C max , AUC 0– t , and AUC 0– ∞ for lamivudine, zidovudine, and nevirapine were within the 80%–125% BE limits 92…”

“…The 90% CI for the geometric mean ratio of test/reference for C max , AUC 0-t , and AUC 0-∞ for lamivudine, zidovudine, and nevirapine were within the 80%-125% BE limits. 92…”

A randomized two-way crossover bioequivalence study in healthy adult volunteers of paediatric zidovudine/lamivudine/nevirapine fast-disintegrating fixed-dose combination tablet

“…A total of 800 μl of clear supernatant liquid was evaporated under nitrogen at 37 °C, and the solid residue thus obtained was dissolved in 25 m m potassium phosphate buffer and analysed by HPLC. The detailed method including the drug extraction and validation is reported elsewhere . The chromatograms were extracted for each sample, and ratio of the peak area of drug to the internal standard was evaluated against the calibration samples to estimate the drug concentrations.…”

“…The detailed method including the drug extraction and validation is reported elsewhere. [20,21] The chromatograms were extracted for each sample, and ratio of the peak area of drug to the internal standard was evaluated against the calibration samples to estimate the drug concentrations.…”