Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-02-17
Brief Title:
A Single Dose Randomized Five-Way Crossover Pharmacokinetics PK Study of Tadalafil Semi-Chewable Gummy Formulations in Healthy Volunteers
Sponsor:
Seattle Gummy Company
Organization:
Seattle Gummy Company
Study Overview
Official Title:
A Single Dose Randomized Five-Way Crossover Pharmacokinetics PK Study of Tadalafil Semi-Chewable Gummy Formulations in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This is an open-label single dose randomized five-period crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg Test and tadalafil oral tablets 10 mg Reference under fasted conditions in healthy adult male and female subjects and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food when administered with or without water and when chewed or swallowed whole
Each subject will receive tadalafil gummy 10 mg or tadalafil tablet and thereby will be hishers own control
Each subject will receive tadalafil gummy 10 mg or tadalafil tablet and thereby will be hishers own control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None