Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers.

NCT03497715 | Terminated Phase 1

• 1 other identifier: NL1401
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Radioactive counts

  radioactivity counts as determined by gamma scintigraphy imaging

  3 hours

Study Arms (4)

Experimental 1

EXPERIMENTAL

Treatment order: Ibuprofen liquid capsules, Ibuprofen sodium, Ibuprofen (Nurofen), Ibuprofen lysine, Ibuprofen (Wockhardt)

Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)

Experimental 2

EXPERIMENTAL

Treatment order: Ibuprofen lysine, Ibuprofen (Wockhardt), Ibuprofen sodium, Ibuprofen (Nurofen), Ibuprofen liquid capsules

Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)

Experimental 3

EXPERIMENTAL

Treatment order: Ibuprofen liquid capsules, Ibuprofen (Nurofen)1, Ibuprofen sodium, Ibuprofen (Wockhardt), Ibuprofen lysine

Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)

Experimental 4

EXPERIMENTAL

Treatment order: Ibuprofen (Wockhardt), Ibuprofen (Nurofen), Ibuprofen lysine, Ibuprofen liquid capsules, Ibuprofen sodium

Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)

Interventions

Ibuprofen lysine DRUG

Test 1

Also known as: Nurofen Migraine pain

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Ibuprofen Sodium DRUG

Test 2

Also known as: Nurofen Express

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Ibuprofen DRUG

Test 3

Also known as: Nurofen Immedia

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Ibuprofen (Nurofen) DRUG

Reference 1

Also known as: Nurofen

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Ibuprofen (Wockhardt) DRUG

Reference 2

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: \> 18 to \< 50 years.
• Sex: Male.
• Status: Healthy volunteers.

You may not qualify if:

• A history of significant disease of any body-system.
• Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
• A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) or the excipients of the formulations.
• A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastrointestinal bleed, or other significant gastro-intestinal disorders.
• A history of frequent dyspepsia, e.g., heartburn or indigestion.
• A history of migraine.
• A history of psychotic illness, attempted suicide or parasuicide.
• Current smokers and ex-smokers who have smoked within 6 months.
• A history of drug abuse (including alcohol).
• High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg (1 cup of coffee equates to 50 mg).
• Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
• Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
• Ingestion of an over-the-counter preparation within 7 days before dosing with study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.
• Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
• Those unable in the opinion of the Investigator to comply fully with the study requirements.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 13, 2018
• Study Start: April 14, 2015
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: April 13, 2018

Record last verified: 2018-03