CompletedPhase 1ACTRN12613000197730

Study of the pharmacokinetics [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 paracetamol and phenylephrine tablets relative to concomitant administration of Sudafed Nasal Decongestant and Panadol after an oral administration of two tablets to healthy adults under fasting conditions


Sponsor

AFT Pharma

Enrollment

30 participants

Start Date

Mar 3, 2013

Study Type

Interventional

Conditions

Summary

To measure the pharmacokinetics [how the body treats drugs] of phenylephrine in humans since this is still not well understood


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

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 and dose: Paracetamol 1000mg and Phenylephrine 10mg Dose frequency: single dose Duration Administration: single dose Mode Administration: Oral tablet Wash-out between treatments = 7 days

Drug and dose: Paracetamol 1000mg and Phenylephrine 10mg Dose frequency: single dose Duration Administration: single dose Mode Administration: Oral tablet Wash-out between treatments = 7 days


Locations(1)

Jordan

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ACTRN12613000197730