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已发表论文
空腹健康中国男性志愿者服用 2 种恩丹西酮 (Ondansetron) 口服水溶性薄膜制剂的药代动力学和生物利用度研究
Authors Zhu YB, Zhang Q, Zou JJ, Wan M, Zhao Z, Zhu JR
Received 10 April 2015
Accepted for publication 19 May 2015
Published 12 August 2015 Volume 2015:9 Pages 4621—4629
DOI http://dx.doi.org/10.2147/DDDT.S86415
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Professor Wei Duan
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.
Purpose: This study was conducted to compare the bioavailability of two 8 mg ondansetron oral soluble film formulations.
Patients and 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.
Conclusion: 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.
Keywords: ondansetron, oral soluble film, LC-MS/MS, bioequivalence
Purpose: This study was conducted to compare the bioavailability of two 8 mg ondansetron oral soluble film formulations.
Patients and 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.
Conclusion: 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.
Keywords: ondansetron, oral soluble film, LC-MS/MS, bioequivalence
