Pharmacokinetics Clinical Trial
Official title:
B l u e C Q - P r o j e c t: Bioavailability of Methylene Blue (MB) - Comparison of an Intravenous and Two Oral Formulations - and Influence of Sustained Release MB on Chloroquine (CQ) Concentrations
Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations
- and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood,
plasma and urine.
Intraindividual cross over open comparison in healthy male and female individuals (6:6) with
different MB formulations in randomised order for the determination of the absolute
bioavailability of MB (part 1), followed by an explorative randomised parallel group
comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in
combination with 1000 mg sustained release MB (3 males and 3 females) in the participants of
study part 1 (part 2).
Maximum whole blood methylene blue (MB) concentrations after i.v. and oral administration
may differ in the magnitude of 100:1. For achieving MB concentrations possibly effective
against malaria when using different pharmaceutical formulations, determination of oral
bioavailability of MB is necessary. To investigate this 12 healthy subjects (6 females, 6
males) will receive in a randomised cross over design MB 50 mg i.v. and MB 500 mg as a oral
solution.
For generating this information for a planned phase II/III study in Africa, an intravenous
and an oral MB preparation will be investigated.
A second part of the study will explorative investigate the influence of MB on chloroquine
(CQ) plasma concentrations. During this part 6 healthy subjects (3 females, 6 males) will
receive either CQ alone or in combination with MB 500 mg, the design of this part will be a
parallel design.
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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