BIOEQUIVALENCE AND PHARMACOKINETIC COMPARISON BETWEEN CLONIDINE HYDROCHLORIDE TABLETS 0.3MG: AN OPEN LABEL, BALANCED, RANDOMIZEDSEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY MALE VOLUNTEERS

Authors

  • Manoj Kumar.M ClinSync clinical Research Pvt Ltd, Hyderabad, Telangana, India.
  • Swetha Savakula ClinSync clinical Research Pvt Ltd, Hyderabad, Telangana, India.
  • Nageswara Rao Pilli Piramal clinical research, Hyderabad,Telangana, India.
  • S.Sai Satyanaraya Reddy Vardhaman College of Engineering, Hyderabad, Telangana, India.
  • Ravindra Reedy.S Vardhaman College of Engineering, Hyderabad, Telangana, India.

Keywords:

Clonidine Hydrochloride, Bioavailability, Bioequivalence, Intrasubject Variability

Abstract

Background: This present bioequivalence study was designed to determine the pharmacokinetic, bioavailability and bioequivalence of Clonidine Hydrochloride 0.3mg Tablets In Comparison With CatapresTM Clonidine Hydrochloride 0.3mg Tablets after single dose administration under fasting conditions in healthy adult male subjects. Therefore the design of an open label, balanced, randomized, two-sequence, single dose, two way crossover study with a wash-out period of at least 7 days was used. Methods: An open-labeled, balanced, single-dose with food, two-treatment, twoperiod, two-sequence, randomized crossover study was conducted in 12 healthy male volunteers. Each volunteer received a 0.3mg Tablet of the reference or test drug respectively. On the day of dosing, blood samples were collected before dosing and at various time points up to 96 hours after dosing. Analysis of clonidine concentrations was performed using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. Results: The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (Cmax, AUC0-t and AUC0-inf) 90%CI were
within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The geometric mean ratios (Test/Reference) between the two products of 0.3mg tablets under fasting condition were 95.49% (89.92%-116.23%) for Cmax ratios, 82.51% (91.41%-110.5%) for AUC0-t ratios and 94.93% (93.64%-108.96%) for AUC0-inf
ratios of Clonidine. 12 volunteers had completed both treatment periods. There was no significant difference of the Tmax parameter between the two formulations (p>0.05). No serious adverse events related to the study drugs were found. Conclusion: This single dose study found that the test formulation Clonidine Hydrochloride 0.3mg Tablets Are Bioequivalent to the Reference
Formulation CatapresTM Clonidine Hydrochloride 0.3mg Tablets In terms of extent and rate of absorption, under fasting condition in healthy adult male volunteers according to the USFDA regulatory guidance. 

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Published

2015-09-11
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Manoj Kumar.M, Swetha Savakula, Nageswara Rao Pilli, S.Sai Satyanaraya Reddy, and Ravindra Reedy.S. “BIOEQUIVALENCE AND PHARMACOKINETIC COMPARISON BETWEEN CLONIDINE HYDROCHLORIDE TABLETS 0.3MG: AN OPEN LABEL, BALANCED, RANDOMIZEDSEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY MALE VOLUNTEERS”. International Journal of Pharmaceutics and Drug Analysis, vol. 3, no. 9, Sept. 2015, pp. 264-9, https://ijpda.com/index.php/journal/article/view/170.

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