Ibuprofen Bioavailability Study

NCT03180879 | Completed Phase 1

• 1 other identifier: RB7-UK-1604
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.

  The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis 0-12hrs

• Cmax - the maximum observed plasma concentration.

  The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis 0-12hrs

Secondary Outcomes (8)

• AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.

  PK Analysis 0-12hrs

• Cmax - the maximum observed plasma concentration.

  PK Analysis 0-12hrs

• Kel - Elimination rate constant

  PK Analysis 0-12hrs

• AUC0-inf - Area under the plasma concentration-time curve from administration to infinity

  PK Analysis 0-12hrs

• AUCR - Ratio AUC0-t/AUC0-inf

  PK Analysis 0-12hrs

Other Outcomes (7)

• Overall proportion of subjects with adverse events (AEs), i.e. the occurrence of one or more AEs per subject

  Through study completion - Screening to study follow-up (approx 6 weeks)

• Change from baseline in oral temperature.

  Through study completion - Screening to study follow-up (approx 6 weeks)

• Change from baseline in resting heart rate.

  Through study completion - Screening to study follow-up (approx 6 weeks)

Study Arms (6)

1

EXPERIMENTAL

Treatment Order: Test, Reference, Comparator

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

2

EXPERIMENTAL

Treatment Order: Test, Comparator, Reference

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

3

EXPERIMENTAL

Treatment Order: Reference, Test, Comparator

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

4

EXPERIMENTAL

Treatment Order: Reference, Comparator, Test

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

5

EXPERIMENTAL

Treatment Order: Comparator, Test, Reference

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

6

EXPERIMENTAL

Treatment Order: Comparator, Reference, Test

Drug: Test - RB ibuprofen acid orodispersible tablets; Drug: Reference - RB Nurofen ibuprofen acid tablets; Drug: Comparator - Dolormin ibuprofen lysine tablets

Interventions

Test - RB ibuprofen acid orodispersible tablets DRUG

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

1; 2; 3; 4; 5; 6

Reference - RB Nurofen ibuprofen acid tablets DRUG

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

1; 2; 3; 4; 5; 6

Comparator - Dolormin ibuprofen lysine tablets DRUG

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

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects who have given written informed consent.
• Age: ≥ 18 years ≤ 50 years.
• Body Mass Index (BMI) of ≥ 18.0 and ≤ 30 kg/m2.
• Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
• 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.
• Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
• 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.

You may not qualify if:

• Pregnant or lactating females.
• A history and/or presence of significant disease of any body system, including significant psychiatric disorders, parasuicide.
• Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
• 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
• A history of or active peptic or duodenal ulcers or gastrointestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
• A history of frequent dyspepsia, e.g. heartburn or indigestion.
• A history of significant and frequent migraine.
• 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.
• A history of substance abuse (including alcohol).
• 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).
• Those with positive test for drugs of abuse and alcohol.
• 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.).
• 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.
• Those who have consumed grapefruit or grapefruit juice, pumelo or Seville oranges in the 7 days before the first dose of study medication.
• Donation of blood \> 400 mL e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research

Merthyr Tydfil, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31202508 DERIVED

Study Officials

• Annelize Koch, MBBS

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: June 8, 2017
• Study Start: April 10, 2017
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)