Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03018015
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: SocraTec R&D GmbH
• Public title: Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
• Scientific 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
• Date of first enrolment: September 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03018015
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Cornelius Koch, MD
• Affiliation: SocraTec R&D GmbH, Clinical Pharmacology Unit

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bioequivalence

Intervention(s)

Drug: Ibuprofen 400 mg oral powder

Drug: Ibuprofen 400 mg soft capsule

Drug: Ibuprofen 400 mg film-coated tablet

Primary Outcome(s)

Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen [Time Frame: 16 hours interval]

Peak Plasma Concentration (Cmax) for ibuprofen [Time Frame: 16 hours interval]

Secondary Outcome(s)

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

Secondary ID(s)

1325ib16ct

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SocraMetrics GmbH