Clinical Trials Logo
NCT number NCT03497715
Study type Interventional
Source Reckitt Benckiser Healthcare (UK) Limited
Contact
Status Terminated
Phase Phase 1
Start date April 14, 2015
Completion date July 30, 2015

Clinical Trial Summary

The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study in healthy subjects, to investigate the rate and site of tablet disintegration of various forms of Ibuprofen.


Clinical Trial Description

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and anti-pyretic properties. There are now a wide variety of formulations of ibuprofen available on market in which the active ingredient, ibuprofen, is either as the free acid, salt or salt in situ. As a result of differences between these formulations, differences in absorption and time to effectiveness are achieved. Rates of absorption are commonly assessed using pharmacokinetic (PK) studies, where the time taken for therapeutic plasma concentration levels to be reached can be determined, with associated absorption profiles being generated.

Before absorption can occur the product must disintegrate in the stomach and empty into the small intestine. Gamma scintigraphy may be used to assess the disintegration rate (of tablets/capsules/caplets) by acquiring images of the investigational medicinal product (IMP) in vivo. Through the use of radiolabelled dosage forms, it enables the visualisation of key stages preceding absorption, including tablet disintegration and the rate of gastric emptying. The assessment of these stages, which are required prior to absorption in the small intestine, may be useful in gaining an understanding of the differences between the dosage forms. The main purpose of this study is to visualise and determine the rate of disintegration and subsequent availability for absorption of different ibuprofen formulations, by gamma scintigraphy.

The study will be conducted in two parts. Part 1 will be conducted as a pilot phase where each subject will receive all 5 IMPs over 5 treatment visits (one IMP/visit).

The data generated in Part 1 will be assessed and used to determine whether to continue to Part 2 as planned, continue to Part 2 with adaptations or stop the study. Adaptations may involve altering the radiolabelling procedure and/or the gamma scintigraphy procedure and/or associated time-points and/or redefining primary/secondary endpoints and statistical analyses.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Active, not recruiting NCT03224793 - Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects. Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1
Completed NCT02532998 - A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects Phase 1
Active, not recruiting NCT02164032 - The Role of IntraNasal Insulin in Regulating HepaTic Lipid COntent in HUMANS Phase 2
Completed NCT02237729 - A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) Phase 1
Completed NCT02173392 - A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab Phase 1
Completed NCT02225288 - A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males Phase 1
Completed NCT02279485 - A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects Phase 1
Completed NCT02252731 - A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects Phase 1
Completed NCT02161796 - A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects Phase 1
Completed NCT02161224 - A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function Phase 1
Completed NCT02218099 - A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease Phase 1/Phase 2
Completed NCT01817855 - To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients Phase 1
Completed NCT01862601 - JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers Phase 1
Completed NCT01791569 - Pulse Oximetry- Evaluating Sensor Off- PCBA-1 N/A