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An evaluation of the drug interaction potential of extended-release felodipine in healthy volunteers, using a cocktail approach

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000811909
Enrollment
12
Registered
2011-08-02
Start date
2011-08-09
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 continu

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Aged 18-50

Exclusion criteria

taking medications significant health conditions unable to comply with study requirements

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026