title: Pharmacokinetics and bioavailability study of two ondansetron oral soluble film formulations in fasting healthy male Chinese volunteers.
abstract: BACKGROUND
  Ondansetron oral soluble film is designed to be applied on top of the tongue without requiring water to aid dissolution or swallowing, which is especially fitting for nausea and vomiting patients.
  
  
  OBJECTIVE
  This study was conducted to compare the bioavailability of two 8 mg ondansetron oral soluble film formulations.
  
  
  METHODS
  This randomized, open-label, two-period crossover study was performed under fasting conditions. A total of ten eligible subjects were randomly assigned at a 1:1 ratio to receive a single 8 mg dose of the test and reference ondansetron oral soluble film formulations, followed by a 1-week washout period and administration of the alternate formulation. The concentrations of ondansetron were assayed using an liquid chromatograph-mass spectrometer/mass spectrometer (LC-MS/MS) method. For analysis of pharmacokinetic properties, including the peak concentration of T max (C max), AUC from time 0 (baseline) to t hours (AUC0- t ), and AUC from baseline to infinity (AUC0-∞), blood samples were obtained at intervals over the 24-hour period after studying drug administration. Tolerability was assessed by monitoring vital signs and laboratory tests (hematology, blood biochemistry, hepatic function, and urinalysis) and by questioning subjects about adverse events.
  
  
  RESULTS
  The mean (standard derivation [SD]) relative bioavailability was 96.5 (23.7%). The 90% confidence intervals (CIs) for the log-transformed ratios of C max and AUC0- t were 84.71%-103.28% and 91.38%-108.60%, respectively (P>0.05). Similar results were found for the data without log-transformation. No statistically significant differences were found based on analysis of variance. No significant adverse events occurred or were reported during the study.
  
  
  CONCLUSIONS
  As the 90% CIs based on the differences between the test and reference formulation were within the 80%-125% range for both the C max and AUC0- t , we concluded that the two formulations were bioequivalent with respect to the rate or the extent of absorption. Both formulations are well tolerated.
authors: Department of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Yubing
authors: Y
authors: Zhu
authors: Department of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Qian
authors: Q
authors: Zhang
authors: Laboratory of Clinical Pharmacology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Jianjun
authors: J
authors: Zou
authors: Department of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Meng
authors: M
authors: Wan
authors: Department of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Zheng
authors: Z
authors: Zhao
authors: Department of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
authors: Junrong
authors: J
authors: Zhu
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002681:China; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004304:Dosage Forms; D065569:Gastrointestinal Absorption; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D017294:Ondansetron / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000932:Antiemetics; D004304:Dosage Forms; D012702:Serotonin Antagonists; D017294:Ondansetron
keywords: LC-MS/MS; bioequivalence; ondansetron; oral soluble film