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| Sponsored by: |
University of Heidelberg |
|---|---|
| Information provided by: | University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00176072 |
Purpose
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).
| Study Type: | Observational |
| Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
| 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 |
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | November 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Good state of health physically and mentally
Exclusion Criteria:
Any regular drug treatment currently or past (within the last 2 months) except for oral contraceptives in females Treatment with a known inhibitor or inducer of drug metabolising enzymes or transport proteins within a period of less than 10 times the respective elimination half-life
Any acute or chronic illness, especially:
Glucose-6-phosphate dehydrogenase deficiency Allergic disposition or history of hypersensitivity reactions Smoking Alcohol or drug abuse
Contacts and Locations More Information
| Study ID Numbers: | K102 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00176072 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Chloroquine diphosphate Chloroquine Methylene Blue |
