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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Sildenafil

• Registration Number: NCT01254396
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-19
• Study Start: 2010-12
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-07
• Results First Submitted QC: 2012-01-07
• Results First Posted: 2012-02-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sildenafil ODT tablet 50 mg, Fasted	Sildenafil	Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.
Sildenafil ODT tablet 50 mg, Fed	Sildenafil	Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.

Primary Outcome Measures

Name	Time	Method
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
Area Under the Curve From Time Zero to Last Quantifiable 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	Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]	0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose	AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Plasma Decay Half Life (t1/2)	0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore