Ibuprofen Bioavailability Study

NCT ID: NCT03180879

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2017-06-13

Brief Summary

This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups.

This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Treatment Order: Test, Reference, Comparator

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

2

Treatment Order: Test, Comparator, Reference

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

3

Treatment Order: Reference, Test, Comparator

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

4

Treatment Order: Reference, Comparator, Test

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

5

Treatment Order: Comparator, Test, Reference

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

6

Treatment Order: Comparator, Reference, Test

Group Type: EXPERIMENTAL

Test - RB ibuprofen acid orodispersible tablets

Intervention Type: DRUG

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Reference - RB Nurofen ibuprofen acid tablets

Intervention Type: DRUG

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Comparator - Dolormin ibuprofen lysine tablets

Intervention Type: DRUG

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

Interventions

Test - RB ibuprofen acid orodispersible tablets

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

Intervention Type: DRUG

Reference - RB Nurofen ibuprofen acid tablets

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

Intervention Type: DRUG

Comparator - Dolormin ibuprofen lysine tablets

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects who have given written informed consent.

2. Age: ≥ 18 years ≤ 50 years.

3. Body Mass Index (BMI) of ≥ 18.0 and ≤ 30 kg/m2.

4. Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.

5. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.

6. Female subject of non-child bearing potential with negative pregnancy test at the screening visit.

7. Male subject willing to use an effective method of contraception unless anatomically sterile or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.

Exclusion Criteria

1. Pregnant or lactating females.

2. A history and/or presence of significant disease of any body system, including significant psychiatric disorders, parasuicide.

3. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.

4. A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other non-steriodal anti-inflammatory drugs (NSAIDs), or the excipients of the formulations

5. A history of or active peptic or duodenal ulcers or gastrointestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.

6. A history of frequent dyspepsia, e.g. heartburn or indigestion.

7. A history of significant and frequent migraine.

8. Current smokers or ex-smokers who have smoked or used nicotine replacement products during the 6 months prior to the first dose of study medication.

9. A history of substance abuse (including alcohol).

10. Consumption of foods or beverages containing caffeine (e.g. coffee, tea, cola and chocolate) above 300 mg caffeine per day, prior to 48 hours of each treatment period. (One cup of coffee equals approximately 50 mg caffeine).

11. Those with positive test for drugs of abuse and alcohol.

12. Ingestion of a prescribed drug at any time in the 14 days before the first dose of study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers 30 days prior to the first dose of study medication (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).

13. Ingestion of an over-the-counter preparation within 7 days before the first dose of study medication, including herbal medications, vitamins, fish oil supplements, ibuprofen and other NSAIDs.

14. Those who have consumed grapefruit or grapefruit juice, pumelo or Seville oranges in the 7 days before the first dose of study medication.

15. Donation of blood > 400 mL e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication.

16. Known human immune deficiency virus (HIV) positive status, or a positive viral serology test.

17. Topical use of ibuprofen within 7 days before the first dose of study medication.

18. Strenuous physical exercise from 48 hours prior to first dose of study medication.

19. Those previously randomised into this study.

20. Those who are an employee at the study site.

21. Those who are a partner or first degree relative of the Investigator.

22. Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of study medication.

23. Those unable in the opinion of the Investigator to comply fully with the study requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simbec Research

INDUSTRY

Sponsor Role: collaborator

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annelize Koch, MBBS

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

Simbec Research

Merthyr Tydfil, , United Kingdom

Countries

United Kingdom

References

Sugar D, Francombe D, da Silva T, Hanid S, Hutchings S. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers. Clin Ther. 2019 Aug;41(8):1486-1498. doi: 10.1016/j.clinthera.2019.04.040. Epub 2019 Jun 12.

Reference Type: DERIVED

PMID: 31202508 (View on PubMed)

Other Identifiers

RB7-UK-1604

Identifier Type: -

Identifier Source: org_study_id