NCT00176072

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

July 1, 2004

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Methylene BlueChloroquinePharmacokineticsBioavailability

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good state of health physically and mentally

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gerd Mikus, MD Bsc

    Department Internal Medicine VI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Study Completion

November 1, 2004

Last Updated

September 15, 2005

Record last verified: 2004-07