Healthy SubjectsPhase 1NCT01381640
A Study to Compare Two Paracetamol Tablets
A Phase 1 study testing Marketed paracetamol and Experimental paracetamol formulation in people with Healthy Subjects, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Marketed paracetamol and Experimental paracetamol formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2010to May 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects who are in good general health
- Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
BIO-IMAGES Research Ltd.
Glasgow, Scotland, G63 0BX
Bio-Images
Glasgow, Scotland, G63 0BX
About this study
Official title: A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
- Conditions
- Healthy Subjects
- Being tested
- Marketed paracetamol, Experimental paracetamol formulation
- Keywords
- paracetamol, healthy volunteer, pharmacoscintography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed paracetamolDrug
marketed formulation
Experimental paracetamol formulationDrug
Experimental formulation
| Study group | Role | What they receive |
|---|---|---|
| Marketed paracetamol | Active comparator | Marketed formulation Receives: Drug: Marketed paracetamol |
| Experimental paracetamol formulation | Experimental | Experimental formulation Receives: Drug: Experimental paracetamol formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Measured: Baseline to 12 hours post dosing
Secondary outcomes (1)
To assess the gastrointestinal transit by qualitative scintigraphic analysis
Measured: Baseline to 12 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 posted27 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: Study was cancelled prior to enrolling any subjects.
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
- 0 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
- NCT01381640
- Sponsor's protocol ID
- A4040689
- Status last verified
- Jul 2016
- First submitted
- 23 Jun 2011
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
- ClinicalTrials.gov ID
- NCT01381640
- Acronym / sponsor ID
- A4040689
- Conditions
- Healthy Subjects
- Keywords
- paracetamol, healthy volunteer, pharmacoscintography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior to enrolling any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 27 Jun 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.
This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed paracetamol | Active comparator | Drug: Marketed paracetamolMarketed formulation |
| Experimental paracetamol formulation | Experimental | Drug: Experimental paracetamol formulationExperimental formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects who are in good general health
- Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Marketed paracetamolmarketed formulation | Drug | Marketed paracetamol |
| Experimental paracetamol formulationExperimental formulation | Drug | Experimental paracetamol formulation |
Primary outcome
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
Time frame: Baseline to 12 hours post dosing
1 secondary outcome
To assess the gastrointestinal transit by qualitative scintigraphic analysis
Time frame: Baseline to 12 hours post dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marketed paracetamol and Experimental paracetamol formulation in people with Healthy Subjects, run by GlaxoSmithKline at 2 sites in United Kingdom.
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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition (time frame: Baseline to 12 hours post 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 6 Jul 2016.