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

  • Shashank Salunke Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India
  • Aafreen Naik Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India
  • Sandip Chaudhari Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India
  • Raviraj Mahajan Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India
  • Ashish Birla Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

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

Keywords: Bioequivalence, Cilnidipine, Calcium channel blocker, Hypertension, Blood pressure

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Author Biographies

Shashank Salunke, Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Aafreen Naik, Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Sandip Chaudhari, Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Raviraj Mahajan, Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Ashish Birla, Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

Unique Pharmaceutical Laboratories, India (A Division of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai, India

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http://ctri.nic.in/Clinicaltrials/WriteReadData/dcgi/6168238804Amelaxanox%20approval.pdf accessed on 14-02-2022
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Salunke S, Naik A, Chaudhari S, Mahajan R, Birla A. A Randomized, Open-Label, Two-way Crossover Bioequivalence Study of Cilacar Tablet Compared with Atelec Tablet in Healthy Volunteers Under Fasting Condition. JDDT [Internet]. 15Mar.2022 [cited 25Sep.2022];12(2):37-2. Available from: https://jddtonline.info/index.php/jddt/article/view/5233