Clinical trial NCT02482155: Ibuprofen (MOMENT ACT ANALGESIC Granules) Pharmacokinetic 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
MOMENTACT
ibuprofen 400 mg
oral
granules
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Cross Research S.A.
First posted: 2015-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Time to Cmax (Tmax) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Apparent terminal elimination rate constant (λz) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Apparent terminal elimination half-life (t1/2,z) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Lag-time from the dosing time point prior to the first measurable plasma concentration (tlag) of ibuprofen
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Time to the first ibuprofen plasma concentration of 5 ug/mL (ton5)
timeFrame: 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:
measure: Time to the first ibuprofen plasma concentration of 10 ug/mL (ton10)
timeFrame: 0, 3, 5, 10, 15, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 hours post-dose
measure: Occurrence of adverse effects
timeFrame: up to 24 hours after administration
Other outcomes:
Locations:
city: Arzo
country: Switzerland
facility: CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:
Study officials:
affiliation: Cross Research S.A.
name: Milko Radicioni, MD
role: PRINCIPAL_INVESTIGATOR
References: