To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01112462

Enrollment

Registered

2010-04-28

Start date

2010-03-31

Completion date

2010-06-30

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections

Keywords

Nasal congestion, Headache

Brief summary

This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Detailed description

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Interventions

DRUGParacetamol 500 mg/Phenylephrine 5 mg tablets

2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period

DRUGParacetamol 1000 mg/Phenylephrine 10 mg sachet

1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female * Caucasians * Aged between 18 and 50 years * BMI ≤ 30 kg/m2 * Clinically normal medical history * Physical normal examination * Normal laboratory test results

Exclusion criteria

* Pregnancy, lactation or intended pregnancy * Hypersensitivity to or intolerant of the study medications * Donation or loss of blood within 90 days preceding the first dose of study medication

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic measurements	during 24 hours following drug administration	Pharmacokinetic measurements including: * Cmax (Maximum concentration) * AUC0-t (Area under the plasma concentration versus time curve from 0h to the lastmeasurable concentration) * AUC0-inf (Area under the plasma concentration versus time curve from 0h to infinity)

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026