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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254383
• Other study ID #: A1481289
• Status: Completed
• Phase: Phase 1
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Sildenafil Tablet
Tablet, 50 mg, Single Dose
• Sildenafil ODT
Orally Disintegrating Tablet, 50 mg, Single Dose
• Sildenafil ODT
Orally Disintegrating Tablet, 50 mg, Single Dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

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

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t) of sildenafil.		Up to 1 month
Primary	Cmax of sildenafil.		Up to 1 month
Secondary	AUC(0-inf) of sildenafil, if data permits.		Up to 1 month
Secondary	Half-life of sildenafil, if data permits.		Up to 1 month
Secondary	Tmax of sildenafil.		Up to 1 month
Secondary	Number of patients with adverse events.		Up to 1 month

External Links

•   To obtain contact information for a study center near you, click here.