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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000090617

Acronym

AFT-MXCF-02

Enrollment

Registered

2014-01-23

Start date

2014-04-14

Completion date

2014-04-22

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 phenylephrine called Maxiclear.

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

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, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests

Outcome results