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Original ArticleOpen Access
Bioequivalence Study of Ondansetron Tablet in Healthy Thai Male Volunteers
Lohitnavy M 
,
Lohitnavy O ,
Chaijittiprasert K ,
Taytiwat P
,
Lohitnavy O ,
Chaijittiprasert K ,
Taytiwat P ORNRAT LOHITNAVY,M.Sc.*,
PRAWIT TAYTIWAT,M.D.**
Objectives : To assess the average bioequivalence of two formulations of 8-mg ondan-
setron tablets -test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome,
USA) -in 14 healthy Thai male volunteers.
Material and Method : In a randomized, single dose, fasting, two-period, crossover study
design with a 1-week washout period, each subject received an 8-mg ondansetron tablet. Serum
samples were collected over a 24-hour period after administration. Subsequently serum concentrations
of ondansetron were analyzed by using a validated HPLC-UV method. Pharmacokinetic parameters
were determined by using non-compartmental analysis.
Results : No significant difference was observed in any of the pharrnacokinetic parameters
analyzed. The time to reach the maximal concentration (T mu' hour), the peak concentration (Cmax' ng/
ml) and the area under the concentration-time curve (AUC
0
_,
ng.hlml) of ondansetron for reference
and test preparations were 2.6
เธ‘
1.8
vs
2.2
เธ‘
0.6, 49.5
เธ‘
18.9
vs
48.5
เธ‘
13.7 and 352.2
เธ‘
184.7
vs
323.8
เธ‘
154.5, respectively. The 90 per cent confidence intervals for Test/Reference ratio of Cmax
and AUC
0
_
were found within the bioequivalence range of 80-125 per cent (90.3-llO.O% and 88.4-
99.6%, respectively).
Conclusion : The bioequivalence of these two ondansetron preparations was demonstrated.
Key word : Bioequivalence, Ondansetron
PRAWIT TAYTIWAT,M.D.**
Objectives : To assess the average bioequivalence of two formulations of 8-mg ondan-
setron tablets -test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome,
USA) -in 14 healthy Thai male volunteers.
Material and Method : In a randomized, single dose, fasting, two-period, crossover study
design with a 1-week washout period, each subject received an 8-mg ondansetron tablet. Serum
samples were collected over a 24-hour period after administration. Subsequently serum concentrations
of ondansetron were analyzed by using a validated HPLC-UV method. Pharmacokinetic parameters
were determined by using non-compartmental analysis.
Results : No significant difference was observed in any of the pharrnacokinetic parameters
analyzed. The time to reach the maximal concentration (T mu' hour), the peak concentration (Cmax' ng/
ml) and the area under the concentration-time curve (AUC
0
_,
ng.hlml) of ondansetron for reference
and test preparations were 2.6
เธ‘
1.8
vs
2.2
เธ‘
0.6, 49.5
เธ‘
18.9
vs
48.5
เธ‘
13.7 and 352.2
เธ‘
184.7
vs
323.8
เธ‘
154.5, respectively. The 90 per cent confidence intervals for Test/Reference ratio of Cmax
and AUC
0
_
were found within the bioequivalence range of 80-125 per cent (90.3-llO.O% and 88.4-
99.6%, respectively).
Conclusion : The bioequivalence of these two ondansetron preparations was demonstrated.
Key word : Bioequivalence, Ondansetron
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