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document
Pharmacokinetics and relative bioavailability of prajmalium bitartrate after single oral dosing . Pharmacokinetics and relative bioavailability of the marketed prajmalium bitartrate tablet ( Neo-Gilurytmal , CAS 2589-47-1 ) compared to an oral solution were investigated in an open , randomized , single-dose two-fold crossover study in 20 healthy male volunteers . One subject was identified to be a poor metabolizer . In the study population with normal metabolic status the two oral formulations proved to be bioequivalent with regard to the pharmacokinetic parameters Cmax , AUC ( 0-Tlast ) , AUC ( 0-infinity ) and Ae ( 24h ) . tmax was prolonged after administration of the tablets . The relative bioavailability of prajmalium bitartrate from the tablet amounted to 112 % . The poor metabolizer demonstrated in both oral formulations high plasma concentrations , increased AUCs and prolonged terminal half-lives as well as increased renal excretion of prajmalium bitartrate .
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Intervention_Pharmacological
prajmalium bitartrate
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Intervention_Pharmacological
prajmalium bitartrate tablet
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Intervention_Pharmacological
Neo-Gilurytmal , CAS 2589-47-1
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Intervention_Pharmacological
oral solution
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Outcome_Other
Pharmacokinetics and relative bioavailability
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Outcome_Physical
Pharmacokinetics
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Outcome_Physical
relative bioavailability
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Outcome_Other
poor metabolizer .
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Outcome_Other
pharmacokinetic parameters Cmax
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Outcome_Other
AUC ( 0-Tlast )
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Outcome_Other
AUC ( 0-infinity )
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Outcome_Other
Ae ( 24h )
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Outcome_Other
tmax
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Outcome_Physical
relative bioavailability
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Outcome_Physical
high plasma concentrations
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Outcome_Physical
increased AUCs and prolonged terminal half-lives as well as increased renal excretion of prajmalium bitartrate
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Participant_Sample-size
20
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Participant_Condition
healthy
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Participant_Sex
male
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Participant_Sample-size
One
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Participant_Condition
poor metabolizer