Comparative pharmacokinetic evaluation of extended release itopride HCl pellets with once daily tablet formulation in healthy human subjects: a two treatment, four period crossover study in fasted and fed condition
| Autor: | Rabia Ismail Yousuf, Sohail Anwer, Muhammad Iqbal Nasiri, Fahad Siddiqui, Muhammad Shoaib, Kamran Zaheer, Faaiza Qazi, Kamran Ahmed |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Chemistry Pharmaceutical Pellets Pharmaceutical Science Biological Availability 02 engineering and technology Pharmacology Bioequivalence 030226 pharmacology & pharmacy 03 medical and health sciences Young Adult 0302 clinical medicine Pharmacokinetics Drug Discovery Benzyl Compounds medicine Humans Cross-Over Studies Chemistry Organic Chemistry Fasting Itopride 021001 nanoscience & nanotechnology Crossover study Healthy Volunteers Bioavailability Therapeutic Equivalency Area Under Curve Benzamides Extended release Once daily 0210 nano-technology medicine.drug Tablets |
| Zdroj: | Drug development and industrial pharmacy. 45(3) |
| ISSN: | 1520-5762 |
| Popis: | In this study, pharmacokinetics (PKs) and bioavailability of newly developed extended release (ER) Itopride HCl 150 mg encapsulated ER pellets (test) and 150 mg Ganaton ER once-daily (OD) tablets (reference) were compared and evaluated under fasted and fed conditions.Twelve healthy human subjects were enrolled in a single dose, randomized; two treatments, two sequences, four period crossover study. A modified and validated liquid chromatographic method was used for the estimation of Itopride HCl in plasma samples. The data were analyzed through non-compartmental model using PK software Phoenix Winnonlin version 7. The outcome was measured on logarithmically transformed data, where p 0.05 was considered as non-significant with 90% CI limit of 0.8-1.25.The CThe test and reference formulations had similar pharmacokinetic parameters in each condition studied. However, an increase in the amount of drug was observed in the fed state. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|