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

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 - Pharmacokinetic study of 3D-printed sildenafil tablets in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49936

Enrollment

Registered

2021-08-09

Start date

2021-12-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Subjects will be administered two 10 mg 3D-printed sildenafil tablet (test product) and a 20 mg sildenafil (Revatio®) tablet (reference product) after a washout interval of at least 7 days.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the ratio of geometric least square means between test and reference product for AUC0-t and the associated 90% confidence interval (CI).	—

Secondary

Measure	Time frame
The secondary endpoints are: • The ratio of geometric least square means between test and reference product for Cmax, AUC0-* and the associated 90% CI; • Other pharmacokinetic parameters: tmax, residual area, t1/2, terminal rate constant (ke); • The safety evaluation: incidence of (treatment-emergent) adverse events, vital signs (blood pressure and heart rate), physical examination, laboratory parameters and electrocardiogram.	—

Measure

Time frame

The secondary endpoints are: • The ratio of geometric least square means between test and reference product for Cmax, AUC0-* and the associated 90% CI; • Other pharmacokinetic parameters: tmax, residual area, t1/2, terminal rate constant (ke); • The safety evaluation: incidence of (treatment-emergent) adverse events, vital signs (blood pressure and heart rate), physical examination, laboratory parameters and electrocardiogram.

—

Countries

Netherlands

Outcome results