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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01254383
Enrollment
36
Registered
2010-12-06
Start date
2010-12-31
Completion date
2011-03-31
Last updated
2021-02-01

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

Conditions

Erectile Dysfunction

Keywords

Bioequivalence Oral Dissolving Tablet

Brief summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

Interventions

DRUGSildenafil Tablet

Tablet, 50 mg, Single Dose

DRUGSildenafil ODT

Orally Disintegrating Tablet, 50 mg, Single Dose

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. Body Mass Index (BMI) of 17.5 to 32.5 kg/m2. Signed and dated informed consent document.

Exclusion criteria

* Evidence or history of clinically significant abnormalities * Have baseline orthostatic hypotension * Positive drug screen, excessive alcohol and tobacco use

Design outcomes

Primary

MeasureTime frame
AUC(0-t) of sildenafil.Up to 1 month
Cmax of sildenafil.Up to 1 month

Secondary

MeasureTime frame
AUC(0-inf) of sildenafil, if data permits.Up to 1 month
Half-life of sildenafil, if data permits.Up to 1 month
Tmax of sildenafil.Up to 1 month
Number of patients with adverse events.Up to 1 month

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026