Pilot Pharmacokinetic Study [the way the body handles drug] of paracetamol and phenylephrine in healthy adults.
Randomised single dose two arm cross-over open label study to determine the bioavailability of a new formulation of paracetamol and phenylephrine tablets [Maxiclear] relative to an oral administration of phenylephrine tablets alone in healthy adults under fasting conditions
AFT Pharma
6 participants
Jun 16, 2013
Interventional
Conditions
Summary
To measure the pharmacokinetics [how the body treats drugs] of phenylephrine in humans since this is still not well understood and to check this specifically for a tablet mixture of paracetamol and phenylephrin called Maxiclear.
Eligibility
Inclusion Criteria1
- Healthy Volunteers
Exclusion Criteria1
- pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, Rx drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests
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Interventions
Drug & Dose: Coadministered Paracetamol 500mg and Phenylephrine 5mg Dose frequency: Single dose Duration Administration: Single dose Mode Administration:Oral tablet Washout between treatments = 7 days
Locations(1)
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ACTRN12613000538741