Carbamazepine is a first-line antiepileptic drug (AED) used for the treatment of partial and tonic-clonic seizures. We conducted an open label, balanced, randomized, two-treatment, two-sequence, four-period, single oral dose, full-replicate crossover study to assess and compare the  bioequivalence of  test  product  Carbamazepine extended release tablets USP 400 mg with reference  product Tegretol®-XR 400 mg (Carbamazepine extended release tablets), respectively in  healthy subjects under fasting and fed conditions. Blood samples were collected pre-dose and at regular intervals post-dose up to 240.00 hours. The plasma concentration was analyzed by a validated LC-MS/MS method and the reference-scaled and the unscaled procedure was used to determine bioequivalence for the pharmacokinetics parameters, Cmax, AUC0–t, AUC0-inf, Tmax, T½, Kel and AUC extrapolated was calculated. The results showed that the geometric mean ratios of Cmax, AUC0–t and AUC0-inf were 113.04%, 108.33% and 108.15% respectively, in the fasting conditions and 113.99%, 110.13% and 111.41%, respectively, in the fed conditions and the 90% confidence intervals were all within the range of 80.00% to 125.00%. It can be concluded from the result that the test product Carbamazepine extended release tablets based on osmotic release system (OROS) are bioequivalent to the reference product Tegretol®-XR tablets. Keywords:  Bioequivalence, Carbamazepine, Sodium Channel Modulators and Epilepsy

Cilnidipine is a novel L/N type calcium channel blocker, approved in several countries world-wide for the treatment of hypertension and is also well-established for its varied pleiotropic benefits. Cilnidipine was first approved in India in 2007, for the treatment of mild to moderate hypertension and since then has been a widely trusted and prescribed molecule. We conducted an open label, analyst blind, randomized, two-treatment, two-period, two sequence, single dose, crossover study to assess and compare the bioequivalence of test product Cilacar 10 mg and 20 mg tablet with reference product Atelec® 10 mg and 20 mg tablet, respectively in healthy volunteers. Blood samples were collected pre-dose and at regular intervals post-dose up to 24 hours. Plasma drug levels were determined with a validated chromatographic method. Pharmacokinetic parameter (Cmax), (AUC0–t), (AUC0–∞), (Tmax), (T½) and (Kel) was calculated. The 90% confidence intervals on the mean of difference between Cilacar 10 mg and Atelec® 10 mg were 82.61% to 121.80%, 88.35% to 109.72%, and 87.54% to 110.52% and The 90% confidence intervals on the mean of difference between Cilacar 20 mg and Atelec® 20 mg were 89.65% to 116.08%, 88.09% to 111.30%, and 88.35% to 110.79% for Cmax, AUC (0-t) and AUC (0–∞) respectively. All the volunteers completed the study. It can be concluded from the results, the test product Cilacar 10 mg and 20 mg and the reference product Atelec® 10 mg and 20 mg tablet met the required bioequivalence criteria. Both products were safe and well tolerated. Keywords Bioequivalence, Cilnidipine, Calcium channel blocker, Hypertension, and Blood pressure