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Nurofen Ibuprofen Orodispersible Tablet Disintegration Study

NCT03658720 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-09-05

No results posted yet for this study

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

Interventions

DRUG

200 mg Ibuprofen acid orodispersible tablet

orodispersible tablet

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Clinical Research Director, Clinical Research · Reckitt Benckiser Healthcare (UK) Limited

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2017-12-21
Completion
2017-12-21

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658720 on ClinicalTrials.gov