Pharmacokinetics of a novel sildenafil orodispersible film administered by the supralingual and the sublingual route to healthy men
| ISRCTN | ISRCTN52182476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52182476 |
| Secondary identifying numbers | Study CRO-PK-17-325, Sponsor code 17CH-SDF06 |
- Submission date
- 17/11/2020
- Registration date
- 25/11/2020
- Last edited
- 25/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
A new oral film containing sildenafil citrate, the active ingredient in Viagra, which is used to treat erectile dysfunction (ED), has been recently developed. It dissolves very rapidly in the oral mouth, with no need for drinking or chewing, thus providing an alternative to the marketed solid oral forms (tablets) in the treatment of ED. This study aims to investigate whether the oral film is absorbed in the same way following two different administration methods: the approved supralingual (dissolved above the tongue) administration and the alternative sublingual (dissolved underneath the tongue) administration.
Who can participate?
Healthy men aged 18-45 years
What does the study involve?
The study has two periods, and participants will be randomly allocated into one section and then will rotate through each period such that every participant completes all periods of the trial but the order will vary depending on the period they are initially allocated to:
Period A: Single dose of the study drug dissolved under the tongue, under fasting
conditions
Period B: Single dose of the study drug dissolved above the tongue, under fasting conditions
There will be a break of at least 5 days between the periods.
The blood level of sildenafil is measured before taking the study drug and again after 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 h.
What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study.
Where is the study run from?
CROSS Research S.A., Phase I Unit (Switzerland)
When is the study starting and how long is it expected to run for?
From November 2017 to December 2017
Who is funding the study?
IBSA Institut Biochimique SA (Switzerland)
Who is the main contact?
Milko Radicioni, MD
clinic@croalliance.com
Contact information
Scientific
CROSS Research S.A
Phase I Unit
Via F.A. Giorgioli 14
Arzo
6864
Switzerland
 ORCID ID |
0000-0002-3940-8375 |
|---|---|
| Phone | +41.91.64.04.450 |
| clinic@croalliance.com |
Study information
| Study design | Single dose, open, randomised, 2-way cross-over pilot bioavailability study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Pilot bioavailability study of sildenafil 50 mg orodispersible film administered by the supralingual and the sublingual route to healthy men |
| Study objectives | To compare the bioavailability of sildenafil and its metabolite N-desmethyl-sildenafil after single dose of sildenafil IBSA 50 mg orodispersible film (ODF), administered by the supralingual and the sublingual route. |
| Ethics approval(s) | Approved 25/09/2017, Cantonal Ethics Committee of the Canton of Ticino (Cantonal Ethics Committee, c/o Health Office, Via Orico 5, 6501 Bellinzona, Switzerland; +41 91 814 30 57; dss-ce@ti.ch), ref: CE3268, BASEC ref: 2017-01622 |
| Health condition(s) or problem(s) studied | Erectile Dysfunction |
| Intervention | The study has two periods, and participants will be randomly allocated into one section and then will rotate through each period such that every participant completes all periods of the trial but the order will vary depending on the period they are initially allocated to: Period A: Single dose of 50 mg sildenafil orodispersible film (ODF) (IBSA Institut Biochimique S.A., Switzerland) by the sublingual administration routes, under fasting conditions Period B: Single dose of 50 mg sildenafil orodispersible film (ODF) (IBSA Institut Biochimique S.A., Switzerland) by the supralingual administration routes, under fasting conditions There will be a break of at least 5 days between the periods. The plasma level of sildenafil is measured before taking the study drug (baseline/0 min) and again after 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 h. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | sildenafil |
| Primary outcome measure | 1. Plasma sildenafil maximum serum concentration (Cmax) and area under the plasma drug concentration-time curve (AUC0-t) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h |
| Secondary outcome measures | 1. Plasma sildenafil time take to reach Cmax (tmax), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (λz) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h 2. Plasma N-desmethyl-sildenafil time take to reach Cmax (tmax), area under the plasma drug concentration-time curve (AUC0-t), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (λz) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h |
| Overall study start date | 06/09/2017 |
| Completion date | 13/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Male |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Signed written informed consent before inclusion in the study 2. Male participants aged between 18-45 years inclusive 3. Body Mass Index (BMI) between 18.5-30 kg/m² inclusive 4. Systolic blood pressure between 100-139 mmHg, diastolic blood pressure between 50-89 mmHg, heart rate between 50-90 bpm (all measured after 5 min at rest in the sitting position) 5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the investigator, and to comply with the requirements of the entire study |
| Key exclusion criteria | 1. Clinically significant abnormalities on electrocardiogram (12-lead ECG in supine position) 2. Clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Clinically significant abnormal laboratory values indicative of physical illness 4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, or history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study 5. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study; history of vision or hearing problems related to drugs of the PDE5 inhibitor pharmacological class; history of priapism; anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease); or history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa |
| Date of first enrolment | 27/11/2017 |
| Date of final enrolment | 13/12/2017 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Arzo
6864
Switzerland
Sponsor information
Industry
via del Piano
Pambio-Noranco
6915
Switzerland
| Phone | +41.58.360.10.00 |
|---|---|
| sd@ibsa.ch | |
| Website | http://ibsa-international.com/ |
"ROR" |
https://ror.org/051tj3a26 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results published in 2018. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/06/2018 | Yes | No |
Editorial Notes
25/11/2020: Trial’s existence confirmed by the Cantonal Ethics Committee of the Canton of Ticino.
