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Trial registered on ANZCTR
Registration number
ACTRN12611000811909
Ethics application status
Approved
Date submitted
2/08/2011
Date registered
2/08/2011
Date last updated
2/08/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
An evaluation of the drug interaction potential of extended-release felodipine in healthy volunteers, using a cocktail approach
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Scientific title
An investigation of the proportional change in area under the concentration-time curves for five orally administered CYP P450 probes (caffeine, losartan, omeprazole, dextromethorphan, midazolam) and one Pgp probe (digoxin) when administered with and without steady-state oral felodipine, in twelve healthy adult volunteers.
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Secondary ID [1]
262760
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Drug-drug interactions
270471
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Condition category
Condition code
Other
270625
270625
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Simultaenous administration of single doses of six drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg, digoxin 250mcg) on two occasions a week apart. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole, digoxin; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of felodipine extended-release 10mg daily, commencing the day after the first administration of the six drug panel and continuing until the time of second administration of the panel. The felodipine will be given as tablets with water.
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Intervention code [1]
267103
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Other interventions
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Intervention code [2]
267105
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Treatment: Drugs
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Comparator / control treatment
not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Probe drug concentrations at various times after administration. Blood will be sampled at the following times - 0h, 0.25h, 05h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and 24h. Plasma drug concentrations will be determined using LC-MS. Clinical assessment and monitoring of heart rate and blood pressure will be used to monitor safety on the days when the six drug combination is given.
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Assessment method [1]
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Timepoint [1]
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Sampling to occur for 24 hours after panel of probe drugs is administered.
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Secondary outcome [1]
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nil
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Assessment method [1]
279439
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Timepoint [1]
279439
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nil
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Eligibility
Key inclusion criteria
Healthy
Aged 18-50
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
taking medications
significant health conditions
unable to comply with study requirements
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
recruited through advertising
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
All participants receive the same drugs at the same point in time according to the protocol. There are two phases to the study which occur sequentially. The AUC for each probe drug is determined without felodipine (in phase 1) and then with felodipine (in phase 2). The phase 1 and phase 2 AUCs are compared for each subject and also as a group. This is standard for this type of drug interaction study.
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Phase
Not Applicable
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/08/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Flinders University
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Address [1]
269581
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Bedford Park
South Australia 5042
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Country [1]
269581
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
Bedford Park
South Australia 5042
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
266615
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Address [1]
266615
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Country [1]
266615
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269533
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Flinders Medical Centre Clinical Research Ethics Committee
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Ethics committee address [1]
269533
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Flinders Medical Center
Flinders Drive
Beford Park
South Australia 5042
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Ethics committee country [1]
269533
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Australia
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Date submitted for ethics approval [1]
269533
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Approval date [1]
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28/07/2011
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Ethics approval number [1]
269533
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1/11/0307
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Summary
Brief summary
To determine whether a commonly used medication for blood pressure (felodipine) could be a cause of interactions with other medication that can lead to adverse effects.
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Trial website
nil
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
32965
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Address
32965
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Country
32965
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Phone
32965
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Fax
32965
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Email
32965
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Contact person for public queries
Name
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Ben Snyder
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Address
16212
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Department of Clinical Pharmacology
Flinders Medical Centre
Bedford Park
South Australia 5042
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Country
16212
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Australia
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Phone
16212
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+61 8 8204 5202
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Fax
16212
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Email
16212
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[email protected]
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Contact person for scientific queries
Name
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Ben Snyder
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Address
7140
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Department of Clinical Pharmacology
Flinders Medical Centre
Bedford Park
South Australia 5042
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Country
7140
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Australia
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Phone
7140
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+61 8 8204 5202
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Fax
7140
0
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Email
7140
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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