A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-65
SponsorSeattle Gummy Company

About this trial

This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers

Eligibility criteria

Qualifiers

male 19-65 years of age;

Available to participate for the planned duration of the study;

Able and willing to complete the informed consent process;

Agree to have blood samples collected and stored for the study;

Disqualifiers

A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;

A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;

subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;

Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;

Trial design

Treatments tested in this trial

  • Tadalafil 10 MG

Treatment groups

30 Participants
are divided into 5 treatment groups

Locations

This trial has no locations

Sponsors and collaborators