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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000197730

Acronym

AFT MXPE02

Enrollment

Registered

2013-02-19

Start date

2013-03-03

Completion date

2013-03-12

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

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

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

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

Outcome results