Clinical trial NCT01737203: Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Viagra
ODT
bioquivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 53
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 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 or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 9 days
measure: Diastolic and Systolic Blood Pressure
timeFrame: 9 days
measure: 12-lead electrocardiogram (ECG)
timeFrame: 9 days
measure: Pulse rate (PR)
timeFrame: 9 days
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: 9 days
measure: Mean Residence Time(MRT)
timeFrame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: