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Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

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ClinicalTrials.gov Identifier: NCT03018015
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
SocraMetrics GmbH
Information provided by (Responsible Party):
SocraTec R&D GmbH

Brief Summary:

The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.

In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.

All 3 immediate release preparations contain 400 mg ibuprofen.


Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Ibuprofen 400 mg oral powder Drug: Ibuprofen 400 mg film-coated tablet Drug: Ibuprofen 400 mg soft capsule Phase 1

Detailed Description:

The clinical trial will be performed in a single centre, open-label, randomised (order of treatments), balanced, 3-period, 6-sequence, single dose change-over design with administration under fasting conditions separated by a washout period of at least 2 treatment-free days.

Blood sample collection will be performed over 16 h after administration. This time is considered adequate to characterise plasma concentration vs. time profiles long enough for reliable estimation of the extent of absorption, i.e. the AUC derived from measurements is expected to cover at least 80 % of the AUC extrapolated to infinity.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Characterisation of Relative Bioavailability of a Newly Developed Ibuprofen Oral Powder Formulation in Comparison With Two Marketed Reference Products in a Single Dose, 3-period-crossover Design Under Fasting Conditions; Controlled, Open-label, Randomised Study With Bioequivalence Assessment
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen 400 mg oral powder
oral fasted administration of 1 sachet of Ibuprofen 400 mg oral powder (Hermes Arzneimittel GmbH, Germany), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg oral powder
Active Comparator: Brufen 400 mg film-coated tablets
oral fasted administration of Brufen 400 mg film-coated tablets (Abbott Scandinavia AB, Sweden), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg film-coated tablet
Active Comparator: Spalt forte 400 mg Weichkapseln
oral fasted administration of Spalt forte 400 mg Weichkapseln (Pfizer Consumer Healthcare GmbH, Germany), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg soft capsule



Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen [ Time Frame: 16 hours interval ]
  2. Peak Plasma Concentration (Cmax) for ibuprofen [ Time Frame: 16 hours interval ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: from first dose until discharge of the subject (approx. 2 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. sex: male/female
  2. ethnic origin: Caucasian
  3. age: 18 years or older
  4. body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m², body weight > 40 kg
  5. good state of health
  6. non-smoker or ex-smoker for at least 3 months
  7. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion Criteria:

  1. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  2. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
  3. existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
  4. history of gastrointestinal bleeding or perforation, related to previous NSAID therapy
  5. existing, or history of, recurrent gastrointestinal ulcer/ bleeding
  6. conditions involving an increased tendency to bleeding
  7. active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease)
  8. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  9. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
  10. history of hypersensitivity reactions (e.g. bronchial spasm, asthma, rhinitis, urticaria, or angioedema) after intake of acetylsalicylic acid or other NSAIDs
  11. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  12. existing, or history of, bronchial asthma, chronic rhinitis or allergic diseases unless it is judged as not relevant for the clinical trial by the investigator
  13. subjects with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
  14. systolic blood pressure < 90 or > 145 mmHg
  15. diastolic blood pressure < 60 or >90 mmHg
  16. heart rate < 50 bpm or > 90 bpm
  17. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator except parameters ASAT, ALAT, bilirubin and creatinine (see exclusion criterion No. 18)
  18. laboratory values: ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 % ULN and creatinine > 9 μmol/l ULN
  19. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCVtest
  20. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
  21. history of or current drug or alcohol dependence
  22. positive alcohol or drug test at screening examination
  23. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g pure ethanol for female per day
  24. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
  25. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
  26. blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
  27. administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
  28. regular treatment with any systemically available medication (except hormonal contraceptives)
  29. subjects, who report a frequent occurrence of migraine attacks
  30. positive pregnancy test at screening examination
  31. pregnant or lactating women
  32. female subjects who do not agree to apply highly effective contraceptive methods
  33. subjects suspected or known not to follow instructions
  34. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.

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): NCT03018015


Locations
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Germany
SocraTec R&D GmbH Clinical Pharmacology Unit
Erfurt, Thüringen, Germany, 99084
Sponsors and Collaborators
SocraTec R&D GmbH
SocraMetrics GmbH
Investigators
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Principal Investigator: Cornelius Koch, MD SocraTec R&D GmbH, Clinical Pharmacology Unit

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Responsible Party: SocraTec R&D GmbH
ClinicalTrials.gov Identifier: NCT03018015     History of Changes
Other Study ID Numbers: 1325ib16ct
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by SocraTec R&D GmbH:
Bioequivalence
Healthy
Bioavailability
Ibuprofen
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