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HealthyPhase 1NCT02482155

Ibuprofen (MOMENT ACT ANALGESIC Granules) Pharmacokinetic Study

A Phase 1 study testing Ibuprofen in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.

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

The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male and female subjects, under fasting conditions. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ibuprofen
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 siteSwitzerland
Study dates
Feb 2015to Mar 2015
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

  • Informed consent: signed written informed consent before inclusion in the study;
  • Sex and age: females and males, 18-55 years old both inclusive;
  • Body Mass Index (BMI): 18.5-30 kg/m2 inclusive;
  • Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position;
  • Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study;
  • Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception:
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  • hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;
  • a non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit;
  • a male sexual partner who agrees to use a male condom with spermicide;
  • a sterile sexual partner. Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test result must be negative at screening and day -1.

Who cannot join

  • Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities;
  • Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study;
  • Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness;
  • Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients or related drugs, namely non-steroidal anti-inflammatory agents (NSAIDs); history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study;
  • Diseases: history of significant renal, hepatic, gastrointestinal (in particular gastroduodenal ulcer and bleeding), cardiovascular, respiratory (in particular asthma), skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study;
  • Medications: medications, including over the counter (OTC) medications and herbal products for 2 weeks before the start of the study, in particular ibuprofen. Hormonal contraceptives for females are allowed;
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  • Investigative drug studies: participation in the evaluation of any investigational product in the 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
  • Blood donation: blood donations in the 3 months before this study;
  • Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to United States Department of Agriculture Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (>=10 cigarettes/day); daily use of distilled spirits;
  • Drug test: positive result at the drug test at screening or day-1;
  • Alcohol test: positive alcohol breath test at day -1;
  • Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study, vegetarians;
  • Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:

    Arzo, CH-6864

Other trials in Switzerland

About this study

Official title: Pharmacokinetic Study of a Single Oral Administration of MOMENT ACT ANALGESIC Granules for Oral Solution to Healthy Volunteers Under Fasting Conditions Single Centre, Single Dose, Open-label, Bioavailability Study

The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male and female subjects, under fasting conditions.

Conditions
Healthy
Being tested
Ibuprofen
Keywords
pharmacokinetics, MOMENTACT, ibuprofen 400 mg, oral, granules

What participants receive

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

  • IbuprofenDrug

    Also called MOMENTACT

    ibuprofen 400 mg single dose oral solution

Study groups in NCT02482155
Study groupRoleWhat they receive
ibuprofenExperimentalibuprofen 400 mg granules, oral solution, single administration under fasting conditions
Receives: Drug: Ibuprofen

What is being measured

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

  1. Maximum plasma concentration (Cmax) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  2. Area under the plasma concentration versus time curve (AUC) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  3. Time to Cmax (Tmax) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  4. Apparent terminal elimination rate constant (λz) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  5. Apparent terminal elimination half-life (t1/2,z) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  6. Lag-time from the dosing time point prior to the first measurable plasma concentration (tlag) of ibuprofen

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  7. Time to the first ibuprofen plasma concentration of 5 ug/mL (ton5)

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

Secondary outcomes (2)

  1. Time to the first ibuprofen plasma concentration of 10 ug/mL (ton10)

    Measured: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose

  2. Occurrence of adverse effects

    Measured: up to 24 hours after administration

Timeline

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

  1. First posted26 Jun 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482155
Sponsor's protocol ID
070(I)HO14386
Other IDs
CRO-PK-14-291
Status last verified
Jun 2015
First submitted
17 Jun 2015
Last updated
26 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.

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 10 inclusion and 13 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 26 Jun 2015. 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 Switzerland. 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?

Maximum plasma concentration (Cmax) of ibuprofen (time frame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose). The study lists 7 primary outcomes in all. 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 NCT02482155.

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 26 Jun 2015.

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