Healthy SubjectsPhase 1NCT01476189
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
A Phase 1 study testing Experimental paracetamol formulation, Marketed paracetamol and Higher dose marketed paracetamol in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
A repeat dose pharmacokinetic study investigating two paracetamol formulations Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Experimental paracetamol formulation, Marketed paracetamol and Higher dose marketed paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Who cannot join
- Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
Trial locations and contacts
1 site in 1 country.
United States1 site
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, 68501
About this study
Official title: A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
A repeat dose pharmacokinetic study investigating two paracetamol formulations
- Conditions
- Healthy Subjects
- Being tested
- Experimental paracetamol formulation, Marketed paracetamol, Higher dose marketed paracetamol
- Keywords
- pharmacokinetic, paracetamol, Healthy volunteer, steady state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental paracetamol formulationDrug
experimental
Marketed paracetamolDrug
Marketed paracetamol
Higher dose marketed paracetamolDrug
Higher dose marketed paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Experimental paracetamol formulation | Experimental | test formulation Receives: Drug: Experimental paracetamol formulation |
| Marketed paracetamol | Active comparator | Marketed paracetamol Receives: Drug: Marketed paracetamol |
| Higher dose marketed paracetamol | Active comparator | higher dose marketed paracetamol Receives: Drug: Higher dose marketed paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence as measured by Area Under the Curve (AUC)
Measured: last 24 hours of dosing
Secondary outcomes (3)
Time duration at or above minimal therapeutic plasma paracetamol concentration
Measured: last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
Measured: last 24 hours of dosing
Adverse events
Measured: Baseline to 72 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476189
- Sponsor's protocol ID
- A2750607
- Status last verified
- Jun 2014
- First submitted
- 17 Nov 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
- ClinicalTrials.gov ID
- NCT01476189
- Acronym / sponsor ID
- A2750607
- Conditions
- Healthy Subjects
- Keywords
- pharmacokinetic, paracetamol, Healthy volunteer, steady state
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Nov 2011 (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.
A repeat dose pharmacokinetic study investigating two paracetamol formulations
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental paracetamol formulation | Experimental | Drug: Experimental paracetamol formulationtest formulation |
| Marketed paracetamol | Active comparator | Drug: Marketed paracetamolMarketed paracetamol |
| Higher dose marketed paracetamol | Active comparator | Drug: Higher dose marketed paracetamolhigher dose marketed paracetamol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Key exclusion criteria (3 listed)
- Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
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 |
|---|---|---|
| Experimental paracetamol formulationexperimental | Drug | Experimental paracetamol formulation |
| Marketed paracetamolMarketed paracetamol | Drug | Marketed paracetamol |
| Higher dose marketed paracetamolHigher dose marketed paracetamol | Drug | Higher dose marketed paracetamol |
Primary outcome
Bioequivalence as measured by Area Under the Curve (AUC)
Time frame: last 24 hours of dosing
3 secondary outcomes
Time duration at or above minimal therapeutic plasma paracetamol concentration
Time frame: last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
Time frame: last 24 hours of dosing
Adverse events
Time frame: Baseline to 72 hours post dosing
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 24 Nov 2014.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Experimental paracetamol formulation, Marketed paracetamol and Higher dose marketed paracetamol in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
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 1 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 24 Nov 2014. 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 United States. 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?
Bioequivalence as measured by Area Under the Curve (AUC) (time frame: last 24 hours of dosing). 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 24 Nov 2014.