Bioequivalence Study of Two Formulations of Ibandronic Acid 150-mg Film-Coated Tablets in Healthy Volunteers Under Fasting Conditions: A Randomized, Open-Label, Three-Way, Reference-Replicated Crossover Study
| Autor: | Pedro Pedroso, Augusto Filipe, Sylvie Boudreault, Rita Neves, Susana Marta Almeida |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Adult
Male Therapeutic equivalency Adolescent Chemistry Pharmaceutical Administration Oral Pharmacology Ibandronic acid Bioequivalence study Young Adult Healthy volunteers medicine Humans Crossover bioequivalence study Original Research Article Aged Cross-Over Studies Diphosphonates Dose-Response Relationship Drug business.industry Fasting Middle Aged Coated tablets Crossover study Healthy Volunteers Absorption Physiological Therapeutic Equivalency Three way Reference-replicated Female Open label business medicine.drug Tablets |
| Zdroj: | Drugs in R&D |
| ISSN: | 1174-5886 |
| DOI: | 10.1007/s40268-014-0044-x |
| Popis: | Aims This bioequivalence study aimed to compare rate and extent of absorption of a generic medicinal product of ibandronic acid 150-mg film-coated tablet versus Bonviva®. Methods This was a single-centre, open-label, randomized, three-way, three-sequence, reference-replicated, crossover bioequivalence study, under fasting conditions. A single oral dose of ibandronic acid as one 150-mg film-coated tablet was administered in each study period. Each washout period lasted 14 days. Blood samples were collected according to a predefined sampling schedule and up to 48.0 hours after administraton in each period. Plasma concentrations of ibandronic acid were measured using a liquid chromatograph–mass spectrometry/mass spectrometry method. Bioequivalence between generic and reference medicinal products is acceptable if the 90 % confidence intervals (CI) of ratio of least-squares means between the test and the reference product of ln-transformed area under the serum concentration–time curve from time zero to time of last measurable concentration (AUC0–t) is within the 80.00–125.00 % interval. Prospectively, a scaled average bioequivalence approach for maximum serum concentration (Cmax) was established. Results 153 healthy volunteers were enrolled and randomized. After the test formulation (T) and first and second Bonviva® (R) dosing, the Cmax was 96.71 ± 90.19 ng/mL, 92.67 ± 91.48 ng/mL and 87.94 ± 60.20 ng/mL and the AUC0–t was 390.83 ± 287.27 ng·h/mL, 388.54 ± 356.76 ng·h/mL and 383.53 ± 246.72, respectively. Ratios of T/R and 90 % CI were 100.92 % (94.35–107.94) for AUC0–t, 100.90 % (94.37–107.88) for AUC0–inf and 102.56 % (95.05–110.67) for Cmax. Conclusions Test formulation of ibandronic acid is bioequivalent in rate and extent of absorption to Bonviva® following a 150-mg dose, under fasting conditions. |
| Databáze: | OpenAIRE |
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