Healthy VolunteerPhase 1NCT01551836
At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations
A Phase 1 study testing Paracetamol formulation 1 and Paracetamol formulation 2 in people with Healthy Volunteer, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. 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 Volunteer
- What is being tested?
- Paracetamol formulation 1 and Paracetamol formulation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Jun 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males in good general heatlh and Body Mass Index between 19-28 kg/m2
Who cannot join
- Disease
- Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders.
- Current or recurrent disease, within 12 months of the screening, that could affect the action, absorption or disposition of the study formulations or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
- Current or relevant previous history, within 12 months of the screening visit, of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatments or procedures.
- Medications
- Current or regular use at screening of any prescription, herbal or Over the Counter (OTC) medication including paracetamol, aspirin, metaclopramide, domperidone, cholestyramine, angiotensin -converting enzyme (ACE) inhibitors, acetazolamide, anticonvulsants, diuretics, methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and oral hypoglycemics within the past 48 hrs and monoamine oxidase inhibitors, tricyclic antidepressants, beta blockers and anticoagulants such as warfarin and heparin within the past 2 weeks.
Show all 25Show fewer
- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to the screening visit (some examples of inducers: barbiturates, theophylline; inhibitors: cimetidine, erythromycin).
- Subjects for whom the use of any of the study drugs is contraindicated.
- Virology Screening Positive screening for serum Hepatitis B surface antigen, Hepatitis C antibodies or human immunodeficiency virus (HIV).
- Drug Screen
- Positive urine screen for drugs of abuse at screening and/or Day-1.
- Positive alcohol breath test on Day-1.
- Smoking
- Smoking more than five cigarettes a day.
- Prior (within 7 days of dosing on Day 1) or current use of any other nicotine containing products, other than cigarettes/pipes/cigars.
- Blood donation Has donated blood or plasma or any other blood product within 3 months of the screening visit. Subjects for whom participation in this study would result in having donated more than 1500 ml of blood within the previous 12 months.
- Nutrition
- Is a vegetarian or is under a sodium restricted diet.
- Has consumed poppy seed containing foods within 3 days prior to the screening visit and admission on Day -1.
- Has consumed food and beverages containing grapefruit, Seville oranges or marmalade within 24 hrs prior to admission on Day -1.
- Has consumed caffeine containing drinks or food (e.g. tea, coffee, chocolate and cola) 24 hrs prior to admission on Day -1.
- Has consumed alcohol 36 hrs prior to admission on Day -1.
- Has undertaken any unusually strenuous physical activity 24 hrs prior to the screening visit or check-in on Day 1.
- Weight Weight below 50 kg.
- Haemoglobin Subjects with haemoglobin level below 12.0 gram /decilitre (dl).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Belfast, Northern Ireland, BT9 6AD
About this study
Official title: A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations
This will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. Subjects will attend a screening visit to check if they are eligible for study participation then within 15 days they will check-in to the unit for a stay of approximately 48 hours (hrs). They will be given a single dose of one of the preparations on the first day and then the other preparation on the next day. Regular blood samples will be taken along with other assessments for safety.
- Conditions
- Healthy Volunteer
- Being tested
- Paracetamol formulation 1, Paracetamol formulation 2
- Keywords
- pharmacokinetics, paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol formulation 1Drug
formulation 1
Paracetamol formulation 2Drug
Formulation 2
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol formulation 1 | Other | Higher dose level of marketed paracetamol (compared to the other dosage arm) Receives: Drug: Paracetamol formulation 1 |
| Paracetamol formulation 2 | Other | Lower paracetamol concentrations Receives: Drug: Paracetamol formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to therapeutic levels of plasma concentration
Measured: within a single day
Secondary outcomes (1)
Mean plasma concentrations
Measured: within a single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- NCT01551836
- Sponsor's protocol ID
- E3870651
- Status last verified
- Mar 2012
- First submitted
- 23 Jun 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations
- ClinicalTrials.gov ID
- NCT01551836
- Acronym / sponsor ID
- E3870651
- Conditions
- Healthy Volunteer
- Keywords
- pharmacokinetics, paracetamol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Mar 2012 (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 will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. Subjects will attend a screening visit to check if they are eligible for study participation then within 15 days they will check-in to the unit for a stay of approximately 48 hours (hrs). They will be given a single dose of one of the preparations on the first day and then the other preparation on the next day. Regular blood samples will be taken along with other assessments for safety.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol formulation 1 | Other | Drug: Paracetamol formulation 1Higher dose level of marketed paracetamol (compared to the other dosage arm) |
| Paracetamol formulation 2 | Other | Drug: Paracetamol formulation 2Lower paracetamol concentrations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males in good general heatlh and Body Mass Index between 19-28 kg/m2
Key exclusion criteria (25 listed)
- Disease
- Medications
- Virology Screening Positive screening for serum Hepatitis B surface antigen, Hepatitis C antibodies or human immunodeficiency virus (HIV).
- Drug Screen
- Smoking
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 formulation 1formulation 1 | Drug | Paracetamol formulation 1 |
| Paracetamol formulation 2Formulation 2 | Drug | Paracetamol formulation 2 |
Primary outcome
Mean time to therapeutic levels of plasma concentration
Time frame: within a single day
1 secondary outcome
Mean plasma concentrations
Time frame: within a single day
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 13 Mar 2012.
Related trials for Healthy Volunteer
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
Not yet recruitingObservational study
Screening Protocol
Pain
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 formulation 1 and Paracetamol formulation 2 in people with Healthy Volunteer, run by GlaxoSmithKline at 1 site 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 1 inclusion and 25 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 13 Mar 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 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 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?
Mean time to therapeutic levels of plasma concentration (time frame: within a single day). 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 13 Mar 2012.