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.
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
| Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
| Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
| Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
| Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
| Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
| Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
| Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
| Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
| Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
| Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
| Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
| Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
| Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
Phase 1 | |
| Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
| Completed |
NCT01276119 -
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
|
Phase 1 | |
| Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 |