A randomized, open-label, single dose two-way cross-over pharmacokinetic study of 3D-printed sildenafil tablets compared to the originator sildenafil tablets in healthy adults
- Conditions
- NA1003745410057166
- Registration Number
- NL-OMON49936
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Healthy volunteers (male) as determined by medical history, clinical
laboratory tests and physical examination.
* 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)
* Clinical laboratory test (biochemistry and haematology blood tests and
urinalysis) results within normal reference range for the investigative site,
or results with acceptable deviations that are judged to be not clinically
significant by the investigator.
2. >= 18 and <= 55 years of age
3. Body weight >50 kg and Body Mass Index (BMI) between 18.5 and 30 kg/m2
4. Written informed consent
5. The ability to fully comprehend the nature and aims of the study, including
possible risks and side effects.
1. Contraindication for sildenafil:
* loss of vision in one eye because of non-arteritic anterior ischaemic optic
neuropathy (NAION) or known hereditary degenerative retinal disorders
* sickle cell anemia
* severe hepatic impairment (Child-Pugh C)
* hypotension (blood pressure <90/50 mmHg)
* recent history of stroke or myocardial infarction (last six months)
2. Anatomical deformation of the penis (such as angulation, cavernosal fibrosis
or Peyronie*s disease)
3. History or presence of clinically significant disease (e.g. multiple
myeloma, leukaemia, bleeding disorders or active peptic ulceration)
4. Clinically significant cardiac abnormalities assessed by electrocardiography
5. Clinically significant abnormal physical findings
6. Clinically significant abnormal laboratory values indicative of physical
illness (including hepatic and renal panels, complete blood count, chemistry
panel and urinalysis).
7. Positive screening test for Hepatitis B, Hepatitis C or human
immunodeficiency virus (HIV))
8. Galactose intolerance
9. Hypersensitivity to the active substance and/or any of the excipients of the
formulations or a history of anaphylaxis to drugs or allergic reactions in
general.
10. Participation in the evaluation of any investigational product or donation
of blood for 3 months before this study
11. History of alcohol or drug abuse within the last year
12. Use of prescription medications within 14 days of study drug administration
or over-the-counter (OTC) medications, herbal supplements, or multivitamins
within 7 days, or drugs that are known to be strong or moderate inhibitors or
inducers of CYP3A4 and CYP2C9 within 30 days of study drug administration or
less than 5 half-lives (whichever is longer), with the exception of paracetamol
(up to 4 gram/day).
13. Positive test for drugs of abuse at screening or pre-dose
14. Unable to abstain from use of tobacco or nicotine containing products
during the trial period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the ratio of geometric least square means between test<br /><br>and reference product for AUC0-t and the associated 90% confidence interval<br /><br>(CI). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are:<br /><br>• The ratio of geometric least square means between test and reference product<br /><br>for Cmax, AUC0-* and the associated 90% CI;<br /><br>• Other pharmacokinetic parameters: tmax, residual area, t1/2, terminal rate<br /><br>constant (ke);<br /><br>• The safety evaluation: incidence of (treatment-emergent) adverse events,<br /><br>vital signs (blood pressure and heart rate), physical examination, laboratory<br /><br>parameters and electrocardiogram.</p><br>