Confirmatory pharmacokinetic study of paracetamol and phenylephrine hydrochloride in healthy adults
Comparative, randomized, single dose, three-period, cross-over open label study to evaluate the pharmacokinetic parameters of a new formulation of paracetamol and phenylephrine tablets (Maxiclear) relative to an oral administration of fixed dose combination of paracetamol 1000 mg and phenylephrine 10 mg and relative to an oral administration of phenylephrine 10 mg tablets alone, in healthy adults under fasting conditions
AFT Pharmaceuticals Ltd
30 participants
Apr 14, 2014
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 phenylephrine called Maxiclear.
Eligibility
Inclusion Criteria1
- Healthy volunteers
Exclusion Criteria1
- pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, prescription 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: Combinations of Paracetamol 1000mg with Phenylephrine 5mg and with Phenylephrine 10 mg Dose frequency: Single dose Duration Administration: Single dose Mode Administration:Oral tablet Washout between treatments = 7 days Treatment arms: 3 Arm 1: Paracetamol 1000 mg and Phenylephrine 5 mg Arm 2: Paracetamol 1000 mg and Phenylephrine 10 mg Arm 3: Phenylephrine 10 mg All participants complete intervention Arms 1 and 2 and control arm 3
Locations(1)
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ACTRN12614000090617