Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176072
Status:
COMPLETED
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
BlueCQ Bioavailability
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bioavailability of methylene blue MB - comparison of an iv 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 66 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
Intraindividual cross over open comparison in healthy male and female individuals 66 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
Detailed Description:
Maximum whole blood methylene blue MB concentrations after iv and oral administration may differ in the magnitude of 1001 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 iv and MB 500 mg as a oral solution
For generating this information for a planned phase IIIII 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
For generating this information for a planned phase IIIII 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None