El-Masry, Soha Mahmoud published the artcilePharmacokinetic and Tolerability Comparison of Sustained and Immediate Release Oral Formulations of Nifedipine Tablet Formulations: A Single-Dose, Randomized, Open-Label, Two-Period, Two-Way Crossover Study in Healthy, Fasting Egyptian Male Volunteers, Name: Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, the main research area is nifedipine tablet oral formulation pharmacokinetics safety tolerability Egypt.
Sustained-release formulation of nifedipine is available in Egyptian community and administered twice daily. This study aimed to to compare pharmacokinetics and safety profiles of a 20 mg SR and IR formulation of nifedipine after single-dose administration in healthy Egyptian subjects. Randomized, crossed open-label two- way clin. trial, in 16 healthy adult volunteers, of 24.75±5.20 years, with BMI 23.26±1.756 were assessed. Blood samples were collected at predefined times for 48 h and analyzed for Nifedipine plasma concentrations using validated reversed phase liquid chromatog. method with UV detection. Pharmacokinetics was determined using non- compartmental model pharmacokinetics and analyzed using one-way ANOVA (P≤0.05). Following a single oral administration, SR formulation had a lower C max, compared to IR formulation (54.46±17.75 , 107.45±29.85 ng/mL, resp.), and T maxwas significantly longer (2.97 vs. 1.13 h) for the SR and IR formulation, resp. There was no significant difference between SR and the IR formulations for AUC 0-lastand AUC 0-∞(326.7±98.28 vs. 309.27±105.53 ng·h·mL -1and 380.9 ± 105.24 vs. 334.36±108.1 ng·h·mL -1, resp.). SR formulation of nifedipine showed similar pharmacokinetics to the IR Formulation (F%=1.049), but it addnl. allows a less frequent administration. Therefore, nifedipine SR and IR formulations were well tolerated and displayed comparable safety profiles.
Drug Research (Stuttgart, Germany) published new progress about Clinical trials. 21829-25-4 belongs to class pyridine-derivatives, name is Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, and the molecular formula is C17H18N2O6, Name: Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate.