Respiratory Tract InfectionsPhase 1NCT01112462
To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
A Phase 1 study testing Paracetamol 500 mg/Phenylephrine 5 mg tablets and Paracetamol 1000 mg/Phenylephrine 10 mg sachet in people with Respiratory Tract Infections, run by McNeil AB at 1 site in Ireland.
Trial summary
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Paracetamol 500 mg/Phenylephrine 5 mg tablets and Paracetamol 1000 mg/Phenylephrine 10 mg sachet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2010to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- Paracetamol 500 mg/Phenylephrine 5 mg tablets, Paracetamol 1000 mg/Phenylephrine 10 mg sachet
- Keywords
- Nasal congestion, Headache
- Medical subject headings
- Respiratory Tract Infections, Nasal Obstruction, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 500 mg/Phenylephrine 5 mg tabletsDrug
Also called Sudafed PE Sinus Pain Relief™
2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
Paracetamol 1000 mg/Phenylephrine 10 mg sachetDrug
Also called Flu Plus Hot Lemon™ sachet
1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
| Study group | Role | What they receive |
|---|---|---|
| Tablet | Experimental | Paracetamol 500 mg/Phenylephrine 5 mg tablet Receives: Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets |
| Sachet | Active comparator | Paracetamol 1000 mg/Phenylephrine 10 mg sachet Receives: Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic measurements
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)
Measured: during 24 hours following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112462
- Sponsor's protocol ID
- SC02009
- Other IDs
- 2009-018093-55, 2009
- Status last verified
- Jul 2012
- First submitted
- 27 Apr 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
- ClinicalTrials.gov ID
- NCT01112462
- Acronym / sponsor ID
- SC02009
- Conditions
- Respiratory Tract Infections
- Keywords
- Nasal congestion, Headache
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet | Experimental | Drug: Paracetamol 500 mg/Phenylephrine 5 mg tabletsParacetamol 500 mg/Phenylephrine 5 mg tablet |
| Sachet | Active comparator | Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachetParacetamol 1000 mg/Phenylephrine 10 mg sachet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male and female
- Caucasians
- Aged between 18 and 50 years
- BMI ≤ 30 kg/m2
- Clinically normal medical history
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol 500 mg/Phenylephrine 5 mg tabletsAlso: Sudafed PE Sinus Pain Relief™2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period | Drug | Tablet |
| Paracetamol 1000 mg/Phenylephrine 10 mg sachetAlso: Flu Plus Hot Lemon™ sachet1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period | Drug | Sachet |
Primary outcome
Pharmacokinetic measurements
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paracetamol 500 mg/Phenylephrine 5 mg tablets and Paracetamol 1000 mg/Phenylephrine 10 mg sachet in people with Respiratory Tract Infections, run by McNeil AB at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic measurements (time frame: during 24 hours following drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.