Delayed Release Diclofenac Sodium Formulation vs Voltaren®

NCT02714842 | Completed Phase 1

• 1 other identifier: FM1501
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, open-label, randomised, three-arm crossover study with a fourth fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the study. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption profiles. The investigators will be looking at:

1. 1.The behaviour of the tablets (when, where and how quickly they break up)
2. 2.The gastric emptying time of the tablets (when they leave the stomach)
3. 3.The gastrointestinal transit of the tablets (how long they take to travel through the gut)
4. 4.Blood levels of the drug (diclofenac)

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal transit parameters - gastric emptying time, small intestinal transit time, and colon arrival time of radiolabel where applicable.

  Composite outcome

  16 hours

Secondary Outcomes (2)

• Scintigraphic analysis to determine the times and sites of onset and complete release of radiolabelled lactose.

  16 hours

• Pharmacokinetic parameters plasma concentration (Cp) at each PK sampling point.

  20 hours

Study Arms (4)

Radiolabelled Diclofenac tablet A

EXPERIMENTAL

Single dose of delayed release diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc

Drug: Radiolabelled Diclofenac Tablet A

Radiolabelled diclofenac tablet B

EXPERIMENTAL

Single dose of delayed release diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc

Drug: Radiolabelled Diclofenac tablet B

Voltaren

ACTIVE COMPARATOR

Single dose of enteric coated diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc

Drug: Diclofenac

Radiolabelled diclofenac tablet C

EXPERIMENTAL

Single dose of delayed release diclofenac sodium (25 mg) tablet radiolabelled with 4 MBq 99mTc

Drug: Radiolabelled Diclofenac tablet C

Interventions

Radiolabelled Diclofenac Tablet A DRUG

Delayed release diclofenac sodium tablet (50 mg)

Also known as: Delayed release diclofenac sodium tablet

Radiolabelled Diclofenac tablet A

Radiolabelled Diclofenac tablet B DRUG

Delayed release diclofenac sodium tablet (50 mg)

Also known as: Delayed release diclofenac sodium tablet

Radiolabelled diclofenac tablet B

Radiolabelled Diclofenac tablet C DRUG

Delayed release diclofenac sodium tablet (25 mg)

Also known as: Delayed release diclofenac sodium tablet

Radiolabelled diclofenac tablet C

Diclofenac DRUG

Enteric coated delayed release diclofenac sodium tablet (50 mg)

Also known as: Voltaren

Voltaren

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged between 18 and 55 years inclusive.
• Weight \& Body mass index (BMI)
• BMI between 18.0 and 29.9 kg/m², inclusive. Body weight ≥50 kg
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

You may not qualify if:

• Current or relevant previous history of severe or uncontrolled disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g., renal, cardiovascular, hepatic, hematologic, endocrine, pulmonary, psychiatric, neurologic, or cerebral disease).
• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
• A history of current or relevant previous non self-limiting gastrointestinal disorders in particular, peptic ulcer disease and/or gastrointestinal bleeding.
• A history of hypersensitivity to aspirin or any other NSAID.
• Suffering from asthma requiring current treatment.
• Currently suffering from disease known to impact gastric emptying, e.g., migraine, insulin-dependent diabetes mellitus.
• Laboratory screening results that suggest an abnormal liver and/or renal function.
• Subject has a screening QTc value of greater than or equal to 450 msec or an ECG that is not suitable for QTc measurements (e.g., poorly defined termination of the T-wave). The ECG taken at screening must be considered not clinically significant by the Investigator/ study physician.
• Currently suffering from bleeding or coagulation disorders.
• As a result of a physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
• Subject has taken prescribed medication within 14 days prior to the first assessment visit which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety. Subjects will be withdrawn from subsequent study days if they commence taking prescribed medication during the study period which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety.
• Subject has taken over-the-counter (OTC) medication within 48 hours prior to each assessment visit. T This includes the use of vitamins and natural or herbal remedies e.g., St John's Wort. Subjects who have taken OTC medication may still be entered into the study if, in the opinion of the physician responsible, the medication will not interfere with the study procedures or compromise safety. The occasional use of paracetamol for pain relief (within its labelled dosage) is permitted but must not be taken within 48 hours of an Assessment Visit.
• Recent history (within the last year) of alcohol or other substance abuse.
• Subject has an average weekly alcohol intake of greater than 21 units. 1 unit is equivalent to one 25 mL single measure of whisky, or a third of a pint of beer or half a standard (175 mL) glass of red wine.
• Subject has positive urine drugs of abuse test at screening. Note: At the discretion of the Investigator, the test may be repeated.

Sponsors & Collaborators

• BDD Pharma Ltd: lead
• Drug Delivery International Ltd: collaborator

Study Sites (1)

Bio Images Research Ltd

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Howard NE Stevens

  BDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)