Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018015
• Other study ID #: 1325ib16ct
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2017
• Last updated: January 10, 2017
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: SocraTec R&D GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Ibuprofen 400 mg oral powder

• Ibuprofen 400 mg film-coated tablet

• Ibuprofen 400 mg soft capsule

Locations

Country	Name	City	State
Germany	SocraTec R&D GmbH Clinical Pharmacology Unit	Erfurt	Thüringen

Sponsors (2)

Lead Sponsor	Collaborator
SocraTec R&D GmbH	SocraMetrics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen		16 hours interval	No
Primary	Peak Plasma Concentration (Cmax) for ibuprofen		16 hours interval	No
Secondary	Number of participants with treatment-related adverse events		from first dose until discharge of the subject (approx. 2 weeks)	Yes