Nurofen Ibuprofen Orodispersible Tablet Disintegration Study

NCT03658720 | Terminated

• 1 other identifier: 0414106
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. The standard recommended over-the counter dose of 200mg Nurofen ibuprofen ODT is one (200mg) to two (400mg) tablets. To reflect this, the disintegration time of both one (200mg) and two (400mg) tablets will be assessed in this study. Studies have been performed assessing in vivo ODT disintegration time and have created standardised oral conditions by giving water prior to dosing, to moisten/wet the mouth. In this study it is therefore necessary to standardise the oral conditions as much as possible, despite the interpersonal variability, to measure the time it takes for the ODT to disintegrate. For this study, 20 mL of water is swallowed prior to dosing to standardise oral conditions. Thirty-three healthy volunteers are required to be randomised into the study, to allow evaluable data to be obtained for 30 subjects. Subjects are given a light meal/snack and then fast for 2 hours 15 minutes (± 15 minutes) before dosing, in order to bring the oral cavity environment as close as possible to standard levels and to minimise variability in salivation. Directly before dosing, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects are dosed according to the sequence they have been randomised and the ODT disintegration time assessed. Following the first dose, subjects complete a washout period of a minimum of 4 hours, in accordance with the recommended posology, before receiving the second dose. During this washout period, subjects are given a second light meal/snack (the same as the previous light meal/snack), timed to allow subjects to fast for 2 hours 15 minutes (± 15 minutes) before the second dose. Directly before the second dose, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects then receive the alternative dose to the dose they received during the first assessment, in accordance with the randomisation sequence. Following completion of the disintegration assessments, or upon subject withdrawal, subjects are asked whether they are experiencing any symptoms or complaints. Any AEs are recorded in the CRF and followed up as necessary by the Investigator. Subjects then leave the clinic.Subjects are contacted by the Investigator (or designee) from 24 to up to 48 hours to ensure any AEs are captured.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Tablet disintegration time

  Time to complete tablet disintegration in seconds

  Time of dosing to complete disintegration of the tablet being achieved (2 doses; single assessment day)

Secondary Outcomes (1)

• Number of Adverse Events

  Up to follow up (24-48 hours after assessment day)

Study Arms (2)

Single tablet

EXPERIMENTAL

Ibuprofen acid ODT: 1x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack.

Drug: 200 mg Ibuprofen acid orodispersible tablet

Two tablets

EXPERIMENTAL

Ibuprofen acid ODTs: 2x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack.

Drug: 200 mg Ibuprofen acid orodispersible tablet

Interventions

200 mg Ibuprofen acid orodispersible tablet DRUG

orodispersible tablet

Also known as: Meltlet, Nurofen

Single tablet; Two tablets

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 ≥ 18.5 and ≤ 30 kg/m2.
• Healthy as determined by past medical history, physical examination and vital signs at screening.

You may not qualify if:

• A history of allergy or intolerance (including angioedema, urticaria, bronchospasm, reflux symptoms and rhinitis) related to treatment with ibuprofen, aspirin or other NSAIDs, or the excipients of the formulations.
• A history (treated or untreated) of an oral condition affecting salivation and mouth dryness (e.g. dry mouth, hypersalivation)
• A history of hepatic or renal impairment, hepatic dysfunction, cardiovascular disease, cerebrovascular problems or high blood pressure.
• A history of asthma.
• A history of peptic or duodenal ulcers or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders (including gastro-oesophageal reflux symptoms or gastritis) ulceration, perforation or haemorrhage.
• A history of coagulation disorder or susceptibility to bleeding
• A current or recent (within 2 months) oral issue, which in the opinion of the Principal Investigator could interfere with the study (e.g. mouth ulcers, aphthous ulcers, herpetic disease, oral candidiasis, burning mouth syndrome, geographic tongue, oral swellings, sores or lesions.
• Those currently suffering from dehydration
• A current or history of oral piercing.
• A current or recent history (within one year of the study) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents
• Those with a positive screen/test for drugs of abuse and/or alcohol
• Those who consume more than 14 units of alcohol per week, and where this consumption is spread over less than 3 days, or those who regularly (weekly) consumed excessive amounts of alcohol (\>8 units for men and \>6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics)
• Those who had consumed alcohol within the 24 hours before enrolment onto the study.
• Those who had regularly consumed excessive quantities of caffeine (\>6 cups of tea, coffee or cola per day), according to the Investigator's judgment.
• Those who had consumed caffeine-containing food and drinks within the 24 hours before enrolment onto the study.

Sponsors & Collaborators

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

Study Sites (1)

Simbec Reseach Limited

Merthyr Tydfil, United Kingdom

Location

Study Officials

• Clinical Research Director, Clinical Research

  Reckitt Benckiser Healthcare (UK) Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: September 5, 2018
• Study Start: December 19, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)