Trials / Withdrawn
WithdrawnNCT04391868
A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form
PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY, 6-SEQUENCE CROSSOVER STUDY TO DEMONSTRATE BIOEQUIVALENCE OF SILDENAFIL ORALLY-DISINTEGRATING FILM 50 MG WITH OR WITHOUT WATER TO ORAL TABLET OF SILDENAFIL CITRATE (VIAGRA(Registered)) 50 MG UNDER FASTED CONDITION IN HEALTHY MALE PARTICIPANTS
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the bioequivalence of Sildenafil ODF 50 mg to Viagra® tablet 50 mg under fasted conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Viagra Tablet | 50 mg tablet on Day 1 of each period |
| DRUG | Sildenafil Citrate ODF | 50 mg ODF on Day 1 of each period |
| DRUG | Sildenafil Citrate ODF | 50 mg ODF on Day 1 of each period |
Timeline
- Start date
- 2021-01-30
- Primary completion
- 2021-04-28
- Completion
- 2021-04-28
- First posted
- 2020-05-18
- Last updated
- 2021-02-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04391868. Inclusion in this directory is not an endorsement.