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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000538741

Acronym

AFT-MXCF-1

Enrollment

Registered

2013-05-14

Start date

2013-06-16

Completion date

2013-06-30

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 and to check this specifically for a tablet mixture of paracetamol and phenylephrin called Maxiclear.

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

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