Pharmacokinetics and bioequivalence testing of generic ondansetron preparations in healthy Thai male volunteers
Pharmacokinetics and bioequivalence of oral preparations of generic ondansetron were investigated in healthy Thai males. The test preparations were Vomitron 8 and Vomitron 4, the reference was Zofran. The three products were administered as an 8 mg single oral dose, in a three-period four-sequence c...
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Main Authors: | , , |
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Format: | Clinical Trial |
Language: | English |
Published: |
2014
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Online Access: | http://www.ncbi.nlm.nih.gov/pubmed/3502482 http://cmuir.cmu.ac.th/handle/6653943832/3352 |
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Institution: | Chiang Mai University |
Language: | English |
Summary: | Pharmacokinetics and bioequivalence of oral preparations of generic ondansetron were investigated in healthy Thai males. The test preparations were Vomitron 8 and Vomitron 4, the reference was Zofran. The three products were administered as an 8 mg single oral dose, in a three-period four-sequence cross-over design with one-week washout period. An intravenous 8 mg Zofran was administered on the forth visit. Plasma ondansetron concentrations were determined by HPLC and the pharmacokinetic parameters were analyzed by non-compartmental analysis. |
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