A Randomized, Open-Label, Two-way Crossover Bioequivalence Study of Cilacar Tablet Compared with Atelec Tablet in Healthy Volunteers Under Fasting Condition

Abstract

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