Healthy Volunteer StudyPhase 1NCT02256423

A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects

A Phase 1 study testing REFERENCE 1: Nurofen® 200 mg tablet, REFERENCE 2: Ibuprofen 200 mg soft gel capsule and ibuprofen 200 mg soft gel capsule in people with Healthy Volunteer Study, run by Simbec Research at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to determine the comparative pharmacokinetic profile of the Test Investigational Medicinal Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the reference products Nurofen® 200 mg tablet and ibuprofen… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: REFERENCE 1: Nurofen® 200 mg tablet, REFERENCE 2: Ibuprofen 200 mg soft gel capsule and ibuprofen 200 mg soft gel capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2014to Aug 2014
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 males and females between 18 and 50 years of age.
Female subject of child bearing potential with a negative pregnancy test at the Screening Visit and willing to use an effective method of contraception if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
Female subject of non-child bearing potential with negative pregnancy test at the Screening Visit. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). Menopausal status will be confirmed by demonstrating at screening that levels of follicle stimulating hormone (FSH) fall within the respective pathology reference range. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the Chief Investigator following consultation with the Sponsor's Responsible Physician.
Subject with a Body Mass Index (BMI) of 18-30 kilogram (kg)/metre square (m2). Body Mass Index = Body weight in kg / [Height in m]2.
Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the first dose.
Subject with a negative urinary drugs of abuse screen, determined within 14 days of the first dose (a positive alcohol result may be repeated at the discretion of the Investigator).

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Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
Subject with no clinically significant abnormalities in 12-lead ECG determined within 14 days of the first dose.
Subject must be available to complete the study (including all follow up visits) and comply with study restrictions.
Subject must satisfy a medical examiner about their fitness to participate in the study.
Subject must provide written informed consent to participate in the study.

Who cannot join

History of allergy to NSAIDs or aspirin and history of peptic ulcer or gastrointestinal bleeding.
A clinically significant history of gastrointestinal disorder likely to influence drug absorption, such as Gastroesophageal reflux disease
Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
A clinically significant history of previous allergy / sensitivity to ibuprofen.
A clinically significant history of drug or alcohol abuse.

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Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Donation of 450 mL or more blood within the previous 3 months.
Subjects who are current smokers, or those who have used nicotine products within the previous 3 months.
Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
Any subject who, in the judgment of the Investigator, is likely to be non-compliant with study procedures and/or restrictions during the study, or unable to cooperate because of a language problem or poor mental development.
Subjects must not have taken over the counter drugs and herbal remedies and supplements should not be taken from 7 days prior to the first dose and throughout the duration of the study dosing periods.
Prescribed drugs should not be taken for 7 days before the first dose and throughout the duration of the study dosing periods. This does not include the oral contraceptive pill.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Simbec Research Limited
Merthyr Tydfil, CF48 4DR

Other trials in United Kingdom

About this study

Official title: A Single-dose, Randomised, Crossover Study to Compare the Pharmacokinetics of Three Formulations of Ibuprofen in Healthy Fasting Male and Female Subjects

The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3 Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose). Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1) until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified times throughout the study. There is at least 48 h between dose administrations.

Conditions: Healthy Volunteer Study
Being tested: REFERENCE 1: Nurofen® 200 mg tablet, REFERENCE 2: Ibuprofen 200 mg soft gel capsule, ibuprofen 200 mg soft gel capsule
Keywords: Ibuprofen, healthy volunteer study, pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REFERENCE 1: Nurofen® 200 mg tabletDrug
REFERENCE 2: Ibuprofen 200 mg soft gel capsuleDrug
ibuprofen 200 mg soft gel capsuleDrug

Study groups in NCT02256423
Study group	Role	What they receive
REFERENCE 1: Nurofen® 200 mg tablet	Active comparator	Single group 3-way crossover study Receives: Drug: REFERENCE 1: Nurofen® 200 mg tablet
REFERENCE 2: Ibuprofen 200 mg soft gel capsule	Active comparator	Single group 3-way crossover study Receives: Drug: REFERENCE 2: Ibuprofen 200 mg soft gel capsule
ibuprofen 200 mg soft gel capsule	Experimental	single group, 3-way cross Receives: Drug: ibuprofen 200 mg soft gel capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics
Maximum plasma concentration (Cmax), time to Cmax (tmax), elimination rate constant (λz), terminal half-life (t1/2), area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t), partial area under plasma concentration time curve at the following nominal blood sampling time points 15min, 30min, 45min, 1h, 1.20h, 1.40h and 2h (AU0-n), AUC extrapolated to infinity (AUC0-∞), plasma clearance (CL/F), MRT (mean residence time) and AUC% extrapolated (residual area).
Measured: PK samples are taken up to 12 hours of each study period.

Secondary outcomes (1)

Safety
AEs, vital signs (sitting blood pressure and pulse), ECG (heart rate, PR interval, QRS width, QT interval and QTcB interval) and laboratory (haematology, biochemistry and urinalysis) data.
Measured: participants will be followed for the duration of stay, an expected average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Aug 2014

First posted3 Oct 2014 (estimated)
Study startJul 2014
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Volunteer StudyStudies 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: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256423
Sponsor's protocol ID: RD 680/25772
Status last verified: Sep 2014
First submitted: 16 Sep 2014
Last updated: 3 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteer Study trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Randomised, Crossover Study to Compare the Pharmacokinetics of Three Formulations of Ibuprofen in Healthy Fasting Male and Female Subjects
ClinicalTrials.gov ID: NCT02256423
Acronym / sponsor ID: RD 680/25772
Conditions: Healthy Volunteer Study
Keywords: Ibuprofen, healthy volunteer study, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Simbec ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 3 Oct 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
REFERENCE 1: Nurofen® 200 mg tablet	Active comparator	Drug: REFERENCE 1: Nurofen® 200 mg tabletSingle group 3-way crossover study
REFERENCE 2: Ibuprofen 200 mg soft gel capsule	Active comparator	Drug: REFERENCE 2: Ibuprofen 200 mg soft gel capsuleSingle group 3-way crossover study
ibuprofen 200 mg soft gel capsule	Experimental	Drug: ibuprofen 200 mg soft gel capsulesingle group, 3-way cross

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy males and females between 18 and 50 years of age.
Female subject of child bearing potential with a negative pregnancy test at the Screening Visit and willing to use an effective method of contraception if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
Female subject of non-child bearing potential with negative pregnancy test at the Screening Visit. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). Menopausal status will be confirmed by demonstrating at screening that levels of follicle stimulating hormone (FSH) fall within the respective pathology reference range. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the Chief Investigator following consultation with the Sponsor's Responsible Physician.
Subject with a Body Mass Index (BMI) of 18-30 kilogram (kg)/metre square (m2). Body Mass Index = Body weight in kg / [Height in m]2.
Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the first dose.

Key exclusion criteria (14 listed)

History of allergy to NSAIDs or aspirin and history of peptic ulcer or gastrointestinal bleeding.
A clinically significant history of gastrointestinal disorder likely to influence drug absorption, such as Gastroesophageal reflux disease
Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
A clinically significant history of previous allergy / sensitivity to ibuprofen.

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
REFERENCE 1: Nurofen® 200 mg tablet	Drug	REFERENCE 1: Nurofen® 200 mg tablet
REFERENCE 2: Ibuprofen 200 mg soft gel capsule	Drug	REFERENCE 2: Ibuprofen 200 mg soft gel capsule
ibuprofen 200 mg soft gel capsule	Drug	ibuprofen 200 mg soft gel capsule

Primary outcome

Pharmacokinetics
Time frame: PK samples are taken up to 12 hours of each study period.
Maximum plasma concentration (Cmax), time to Cmax (tmax), elimination rate constant (λz), terminal half-life (t1/2), area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t), partial area under plasma concentration time curve at the following nominal blood sampling time points 15min, 30min, 45min, 1h, 1.20h, 1.40h and 2h (AU0-n), AUC extrapolated to infinity (AUC0-∞), plasma clearance (CL/F), MRT (mean residence time) and AUC% extrapolated (residual area).

1 secondary outcome

Safety
Time frame: participants will be followed for the duration of stay, an expected average of 3 weeks

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 3 Oct 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.

Girish Sharma, MBBS principal investigator

Simbec Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 14 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 3 Oct 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 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?

Pharmacokinetics (time frame: PK samples are taken up to 12 hours of each study period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256423.

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 3 Oct 2014.