Food Effect Study For New Formulation

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01656798
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: sildenafil citrate; Drug: sildenafil citrate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fasted condition	Drug: sildenafil citrate; 2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
Experimental: fec condition	Drug: sildenafil citrate; 2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose

Outcome Measures

Primary Outcome Measures

1. 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]

2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of sildenafil [0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,14 hours post-dose]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] 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]

6. 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]

7. 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]

8. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01656798
• Other Study ID Numbers: A1481313
• First Posted: Aug 3, 2012
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate

Study Results

No Results Posted as of Jan 28, 2021