Ibuprofen (MOMENT ACT ANALGESIC Granules) Pharmacokinetic Study

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02482155
• Date of registration: 17/06/2015
• Prospective Registration: No
• Primary sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Public title: Ibuprofen (MOMENT ACT ANALGESIC Granules) Pharmacokinetic Study
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02482155
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Switzerland

Contacts

• Name: Milko Radicioni, MD
• Affiliation: Cross Research S.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Informed consent: signed written informed consent before inclusion in the study;

2. Sex and age: females and males, 18-55 years old both inclusive;

3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive;

4. 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;

5. 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;

6. Contraception and fertility (females only): females of child-bearing potential must
be using at least one of the following reliable methods of contraception:

1. hormonal oral, implantable, transdermal, or injectable contraceptives for at
least 2 months before the screening visit;

2. 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;

3. a male sexual partner who agrees to use a male condom with spermicide;

4. 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.

Exclusion Criteria:

1. Electrocardiogram (ECG) 12-leads (supine position): clinically significant
abnormalities;

2. Physical findings: clinically significant abnormal physical findings which could
interfere with the objectives of the study;

3. Laboratory analyses: clinically significant abnormal laboratory values indicative of
physical illness;

4. 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;

5. 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;

6. 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;

7. 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;

8. Blood donation: blood donations in the 3 months before this study;

9. 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;

10. Drug test: positive result at the drug test at screening or day-1;

11. Alcohol test: positive alcohol breath test at day -1;

12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating
habits in the 4 weeks before this study, vegetarians;

13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1,
pregnant or lactating women.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Ibuprofen

Primary Outcome(s)

Apparent terminal elimination half-life (t1/2,z) 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]

Time to the first ibuprofen plasma concentration of 5 ug/mL (ton5) [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]

Lag-time from the dosing time point prior to the first measurable plasma concentration (tlag) 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]

Apparent terminal elimination rate constant (?z) 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]

Time to Cmax (Tmax) 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]

Area under the plasma concentration versus time curve (AUC) 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]

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]

Secondary Outcome(s)

Occurrence of adverse effects [Time Frame: up to 24 hours after administration]

Time to the first ibuprofen plasma concentration of 10 ug/mL (ton10) [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]

Secondary ID(s)

070(I)HO14386

CRO-PK-14-291

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cross Research S.A.