title: Bioequivalence study of cyclizine hydrochloride 50 mg tablets in healthy volunteers: a randomized, open-label, single-dose study.
abstract: Cyclizine is used in the treatment and prevention of nausea and vomiting. We aimed to demonstrate bioequivalence between two formulations of cyclizine 50 mg tablets.
  
  
  
  This single-dose, two-treatment, two-period, two-sequence, open-label, randomized crossover study was conducted on 32 healthy male volunteers. The average values for Cmax, Tmax, AUC0-t and AUC0-inf were 21.50 ng/ml, 3.85 h, 423.71 ng.h/ml and 489.26 ng.h/ml, for cyclizine 50 mg (test) versus 20.39 ng/ml, 4.34 h, 410.56 ng.h/ml and 473.86 ng.h/ml for Valoid 50 mg (reference). The 90% CI of the mean ratios of Cmax (geometric mean ratio: 101.81 ng/ml), and AUC0-t (101.81 ng.h/ml) were within the bioequivalence range of 80 to 125%. Both drugs were well tolerated.
  
  
  
  Cyclizine 50 mg is bioequivalent to the reference.
authors.affiliation: Cipla Ltd, R&D Centre, L. B. S. Marg, Vikhroli (West), Mumbai 400 083, India.
authors.forename: Dhiraj
authors.initials: D
authors.lastname: Abhyankar
authors.affiliation: Cipla Ltd, R&D Centre, L. B. S. Marg, Vikhroli (West), Mumbai 400 083, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Shedage
authors.affiliation: Cipla Ltd, R&D Centre, L. B. S. Marg, Vikhroli (West), Mumbai 400 083, India.
authors.forename: Milind
authors.initials: M
authors.lastname: Gole
authors.affiliation: Cipla Ltd, R&D Centre, L. B. S. Marg, Vikhroli (West), Mumbai 400 083, India.
authors.forename: Preeti
authors.initials: P
authors.lastname: Raut
mesh_terms: D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D003501:Cyclizine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D004339:Drug Compounding; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D013607:Tablets; D003501:Cyclizine
keywords: bioequivalence; cyclizine; pharmacokinetics