Healthy SubjectsPhase 1NCT01476215
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
A Phase 1 study testing Paracetamol fast dissolution suspension, Paracetamol medium dissolution suspension and Paracetamol slow dissolution suspension in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Paracetamol fast dissolution suspension, Paracetamol medium dissolution suspension and Paracetamol slow dissolution suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, 68501
About this study
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
- Conditions
- Healthy Subjects
- Being tested
- Paracetamol fast dissolution suspension, Paracetamol medium dissolution suspension, Paracetamol slow dissolution suspension, Paracetamol
- Keywords
- paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol fast dissolution suspensionDrug
Paracetamol medium dissolution suspensionDrug
Paracetamol slow dissolution suspensionDrug
ParacetamolDrug
| Study group | Role | What they receive |
|---|---|---|
| Fast dissolution suspension | Experimental | Not described Receives: Drug: Paracetamol fast dissolution suspension |
| Medium dissolution suspension | Experimental | Not described Receives: Drug: Paracetamol medium dissolution suspension |
| Slow dissolution suspension | Experimental | Not described Receives: Drug: Paracetamol slow dissolution suspension |
| Marketed suspension | Active comparator | Not described Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to plasma level above therapeutic level
Measured: baseline to 8 hours
Secondary outcomes (1)
General PK parameters (e.g. AUC, Tmax, Cmax)
Measured: baseline to 8 hours
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 completionNov 2009
- Study completionNov 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
- 18 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
- NCT01476215
- Sponsor's protocol ID
- A3950669
- Status last verified
- Jun 2014
- First submitted
- 3 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 Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
- ClinicalTrials.gov ID
- NCT01476215
- Acronym / sponsor ID
- A3950669
- Conditions
- Healthy Subjects
- Keywords
- paracetamol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 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.
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fast dissolution suspension | Experimental | Drug: Paracetamol fast dissolution suspension |
| Medium dissolution suspension | Experimental | Drug: Paracetamol medium dissolution suspension |
| Slow dissolution suspension | Experimental | Drug: Paracetamol slow dissolution suspension |
| Marketed suspension | Active comparator | Drug: Paracetamol |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer
- Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
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 |
|---|---|---|
| Paracetamol fast dissolution suspension | Drug | Fast dissolution suspension |
| Paracetamol medium dissolution suspension | Drug | Medium dissolution suspension |
| Paracetamol slow dissolution suspension | Drug | Slow dissolution suspension |
| Paracetamol | Drug | Marketed suspension |
Primary outcome
Time to plasma level above therapeutic level
Time frame: baseline to 8 hours
1 secondary outcome
General PK parameters (e.g. AUC, Tmax, Cmax)
Time frame: baseline to 8 hours
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.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 Paracetamol fast dissolution suspension, Paracetamol medium dissolution suspension and Paracetamol slow dissolution suspension 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 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: 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?
Time to plasma level above therapeutic level (time frame: baseline to 8 hours). 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; AzTrials last refreshed its copy on 8 Nov 2026.