Condition category
Not Applicable
Date applied
04/11/2020
Date assigned
16/11/2020
Last edited
09/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
This is a study of the way food affects the ways a drug is processed by the body. 'Bioavailability' is the amount of the active substance of medicine that reaches the blood flow while the 'pharmacokinetics profile' describes the way the medicine behaves inside the body, after administration, i.e. the absorption, distribution, metabolism and elimination of the substance.
This study is designed to investigate the food effect on the bioavailability and the pharmacokinetics profile of an oral formulation of diclofenac epolamine (DHEP) tablets (each tablet contains 65 mg of diclofenac epolamine corresponding to 50 mg of diclofenac sodium), when administered under fed and fasting conditions to healthy subjects. Diclofenac is a medicine that reduces inflammation and pain.

Who can participate?
Healthy women and men, 18 - 55 years old, can participate. They must comprehend the full nature and purpose of the study, including possible risks and side effects and co-operate with the investigator to comply with the requirements of the entire study. Women of child-bearing potential must be using at least one reliable method of contraception.

What does the study involve?
The study will be conducted at the CROSS Research S.A. Phase I Unit Clinical Centre, in Arzo, Switzerland. Study participants will receive a single oral dose of diclofenac epolamine tablets, under fasting conditions and on a full stomach, in 2 periods, with an interval of at least 5 days between administrations. The formulation to be tested is not yet available on the market in Switzerland, and should therefore be considered a trial product. Participants will have blood samples taken and vital parameters recorded at regular intervals.

What are the possible benefits and risks of participating?
Participating in this study will not bring any direct benefit to participants, with the exception of the medical tests that will be performed during it. As single doses of diclofenac will be administered during this study, no particular risks are expected. However, as with all products, the appearance of allergic reactions or side effects that are known or not yet known cannot be ruled out.

Where is the study run from?
The study will be conducted at the CROSS Research S.A. Phase I Unit Clinical Centre, in Arzo, Switzerland.

When is the study starting and how long is it expected to run for?
August 2019 to November 2019.

Who is funding the study?
IBSA Institut Biochimique S.A. (Switzerland)

Who is the main contact?
Dr Milko Radicioni, clinic@croalliance.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Carol Caverzasio

ORCID ID

http://orcid.org/0000-0002-2697-4271

Contact details

IBSA Institut Biochimique S.A.
Via del Piano 29
PO Box 266
Pambio-Noranco
6915
Switzerland
+41583601000
sd@ibsa.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19CH-GIB05

Study information

Scientific title

Effect of food on diclofenac pharmacokinetics after administration of diclofenac epolamine (DHEP) tablets to healthy volunteers

Acronym

Study hypothesis

This study is designed to investigate the food effect on the bioavailability of an oral formulation of DHEP tablets (each tablet contains 65 mg of diclofenac epolamine corresponding to 50 mg of diclofenac sodium), when administered under fed and fasting conditions to healthy subjects.

Ethics approval

Approved 08/08/2019, Canton Ticino Ethics committee (c/o Ufficio di sanità, Via Orico 5, 6501 Bellinzona, Switzerland; +41(0)91 814 30 57; beatrice.giberti-gai@ti.ch), ref: 2019-01362 / CE 3503

Study design

Single dose open-label randomized two-way cross-over food effect study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Effect of food on diclofenac pharmacokinetics

Intervention

A single dose of the investigational medicinal product (Diclofenac epolamine [DHEP] 65 mg tablet [containing 65 mg of diclofenac epolamine, corresponding to 50 mg of diclofenac sodium]) will be administered to healthy male and female volunteers under fed and fasting conditions in 2 study periods, according to a two-way cross-over design, with a wash-out interval of at least 5 days between the two administrations.

Intervention type

Drug

Phase

Phase I

Drug names

Diclofenac epolamine (DHEP)

Primary outcome measure

Bioavailability of diclofenac assessed by comparing the rate (Cmax) and extent (AUC0-t) of absorption measured using ... during each condition

Secondary outcome measures

Safety and tolerability of diclofenac will be evaluated during each condition by
1. Adverse events measured using self-reports and patient records throughout the study
1.1. Pre-treatment AEs (PTAEs) are all AEs occurring after IC signature by the enrolled subject but before the the first dose of IMP
1.2. Treatment-Emergent AEs (TEAEs) are all AEs occurring or worsening after the administration of the first dose of IMP
2. Vital signs (blood pressure [mmHg], heart rate [bpm]) measured at screening visit, day 1of each period: pre-dose (0) and 8 h post-dose and at early termination visit (if applicable)
3. Bodyweight (kg)
4. Physical examinations are performed at the screening and final visit/early termination visit (ETV) to check subjects’ overall health and the occurrence of any AE throughout the study duration
5. Laboratory parameters:
5.1. Haematology, blood chemistry, serum virology and urine analysis is performed at the screening visit
5.2. A urine drug test is performed at the screening and at the entrance of each study period, using a urine multi-drug kit
5.3. A serum pregnancy test is performed by the laboratory at screening. A urine pregnancy test is performed at the entrance of each study period
5.4. Haematology, blood chemistry are performed at the final visit/ETV
6. Heart rate variability and heart activity measured using ECG at screening and final visit/ETV

Overall trial start date

08/08/2019

Overall trial end date

05/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Age 18 - 55 years old inclusive
3. Body Mass Index: 18.5 - 30 kg/m² inclusive
4. Vital signs: systolic blood pressure 100 - 139 mmHg, diastolic blood pressure 50 - 89 mmHg, heart rate 50 - 90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
6. Contraception and fertility (women): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
6.3. A male sexual partner who agrees to use a male condom with spermicide
6.4. A sterile sexual partner
7. Female participants of non-childbearing potential or in post-menopausal status for at least one year will be admitted
8. For all women, pregnancy test result must be negative at screening and Day -1

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Total final enrolment

20

Participant exclusion criteria

1. Electrocardiogram: 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
6. Medications: medications, including over the counter medications, herbal remedies and supplements for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapy for women will be allowed
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donation: blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day)
10. Drug test: positive result at the drug test at screening or Day -1
11. Alcohol test: positive alcohol breath test at Day -1
12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
13. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women

Recruitment start date

14/10/2019

Recruitment end date

15/10/2019

Locations

Countries of recruitment

Switzerland

Trial participating centre

CROSS Research S.A.
Phase I Unit Via F.A. Giorgioli 14
Arzo
6864
Switzerland

Sponsor information

Organisation

IBSA Institut Biochimique (Switzerland)

Sponsor details

Via del Piano 29
PO Box 266
Pambio-Noranco
6915
Switzerland
+41 583601000
sd@ibsa.ch

Sponsor type

Industry

Website

https://www.ibsagroup.com/

Funders

Funder type

Industry

Funder name

IBSA Institut Biochimique S.A.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To date, there are no plans to public the study results on scientific journals.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/11/2020: Trial’s existence confirmed by Canton Ticino Ethics committee.