Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 10:45 PM
Study NCT ID:
NCT01737203
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Organization:
Study Overview
Official Title:
Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
Status:
COMPLETED
Status Verified Date:
2021-01
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:
The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: