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Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet

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ClinicalTrials.gov Identifier: NCT02902289
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Aziende Chimiche Riunite Angelini Francesco S.p.A

Brief Summary:
The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated tablet, when administered under fasting conditions as single oral dose to healthy male and female volunteers, in two consecutive study periods.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ibuprofen 200 mg/5 mL oral suspension Drug: MOMENT 200 mg coated tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bioequivalence Study of a New Formulation of Ibuprofen 200 mg/5 mL Oral Suspension vs. the Reference Product MOMENT 200 mg Coated Tablet in Healthy Volunteers
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen 200 mg/5 mL oral suspension
Single dose of 1 ibuprofen 200 mg/5 mL stick administered under fasting conditions in two consecutive periods, with a wash-out interval of at least 7 days between consecutive administrations.
Drug: Ibuprofen 200 mg/5 mL oral suspension
Active Comparator: MOMENT 200 mg coated tablet
Single dose of 1 MOMENT 200 mg coated tablet administered under fasting conditions in two consecutive periods, with a wash-out interval of at least 7 days between consecutive administrations.
Drug: MOMENT 200 mg coated tablet



Primary Outcome Measures :
  1. Cmax of (S)-ibuprofen after single dose administration under fasting conditions of test and reference formulations containing racemic ibuprofen. [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
    Maximum plasma concentration (μg/ml)

  2. AUC(0-t) of (S)-ibuprofen after single dose administration under fasting conditions of test and reference formulations containing racemic ibuprofen. [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
    Area under the plasma concentration-time curve from administration time to the time (t) of the last measurable concentration (Ct ), calculated with the linear trapezoidal method (μg*h/ml)


Secondary Outcome Measures :
  1. Peak drug concentration (Cmax) of racemic ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  2. Area under the concentration-time curve from time zero to time t (AUC(0-t)) of racemic ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  3. Area under the concentration-time curve from time zero to time t (AUC(0-t)) ratio of the two enantiomers (S/R) after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
    Area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC(0-t) + Ct/λz, where Ct is the last measurable drug concentration (μg*h/ml)

  4. Area under the concentration vs. time curve up to infinity (AUC(0-∞)) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  5. Extrapolated area calculated as (AUC(0-∞) - AUC(0-t))/AUC(0-∞) (residual area) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  6. Time to achieve Cmax (Tmax) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  7. Half-life lambda z (/t1/2,z) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  8. Apparent First order terminal rate constant (λz) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  9. Time Until First Nonzero Concentration (tlag) of ibuprofen racemate and of (S)-ibuprofen and (R)-ibuprofen after single dose administration under fasting conditions of test and reference formulations [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  10. Treatment-Emergent Adverse Event (TEAEs), vital signs (BP, HR), physical examination, body weight and laboratory parameters [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]
  11. A descriptive evaluation of palatability for the test formulation will be performed. Smell, taste and texture parameters will be evaluated immediately after drug administration through a 5-point rating scale. [ Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be enrolled in this study, subjects must fulfil all these criteria:

  1. Informed consent: signed written informed consent before inclusion in the study
  2. Sex and Age: males/females, 18-55 years old 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 [IUD] 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 (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) (in particular ibuprofen) medications and herbal products for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
  7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
  8. Blood donation: blood donations for 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 USDA Dietary Guidelines 2015-2020 (10)], caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes/day)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902289


Locations
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Switzerland
CROSS Research S.A., Phase I Unit
Arzo, Switzerland, CH-6864
Sponsors and Collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Cross Research S.A.
Investigators
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Principal Investigator: Milko Radicioni, MD Cross Research S.A.

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Responsible Party: Aziende Chimiche Riunite Angelini Francesco S.p.A
ClinicalTrials.gov Identifier: NCT02902289     History of Changes
Other Study ID Numbers: 070(Q)HO15411
CRO-PK-15-306 ( Other Identifier: CROSS Research S.A., Phase I Unit )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aziende Chimiche Riunite Angelini Francesco S.p.A:
Bioequivalence
Ibuprofen 200 mg/5 ml
Moment 200 mg coated tablet
Oral Suspension
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action