MedDataX Logo

To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

NCT ID: NCT01112462

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nasal congestion, Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tablet

Paracetamol 500 mg/Phenylephrine 5 mg tablet

Group Type EXPERIMENTAL

Paracetamol 500 mg/Phenylephrine 5 mg tablets

Intervention Type DRUG

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

Sachet

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Group Type ACTIVE_COMPARATOR

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paracetamol 500 mg/Phenylephrine 5 mg tablets

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

Intervention Type DRUG

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sudafed PE Sinus Pain Relief™ Flu Plus Hot Lemon™ sachet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shandon Clinical Trials Ltd.

Cork, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-018093-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SC02009

Identifier Type: -

Identifier Source: org_study_id