Food Effect Study For New Formulation

Healthy Clinical Trial

Official title:

An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study In Healthy Subjects Assessing The Pharmacokinetics And Safety Of Powder For Oral Suspension Of Sildenafil Citrate Administered Under Fasted And Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656798
• Other study ID #: A1481313
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: August 2012

Study information

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

Clinical Trial Summary

The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 55 years

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

Exclusion Criteria:

• Baseline orthostatic hypotension defined as a =20 mm Hg reduction in systolic blood pressure (SBP), a =10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.

• Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• sildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
• sildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), 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) of sildenafil		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of sildenafil		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of sildenafil		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)of sildenafil		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Plasma Decay Half-Life (t1/2) of sildenafil		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Maximum Observed Plasma Concentration (Cmax) of UK-103,320		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of UK-103,320		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of UK-103,320		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of UK-103,320		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose
Secondary	Plasma Decay Half-Life (t1/2) of UK-103,320		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose

External Links

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