Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

Erectile Dysfunction Clinical Trial

Official title:

An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254396
• Other study ID #: A1481290
• Status: Completed
• Phase: Phase 1
• Start date: December 2010
• Est. completion date: January 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 when given with food and without food.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2011
• Est. primary completion date: January 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 Informed Consent.

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
Orally Disintegrating Tablet, 50 mg, Single Dose
• Sildenafil
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	Maximum Observed Plasma Concentration (Cmax)		0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).	0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-8)]	AUC (0-8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-8). It is obtained from AUC (0-t) plus AUC (t-8).	0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Secondary	Plasma Decay Half Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

External Links

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