A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-02-28

Brief Summary

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The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Revatio: 1 x 20 mg IR oral tablet.

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

Single oral dose of 1 x 20 mg IR oral tablet.

Treatment B

2 x 10 mg sildenafil citrate IR oral tablet.

Group Type EXPERIMENTAL

Sildenafil citrate

Intervention Type DRUG

single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.

Treatment C

2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Interventions

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sildenafil citrate

Single oral dose of 1 x 20 mg IR oral tablet.

Intervention Type DRUG

Sildenafil citrate

single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.

Intervention Type DRUG

sildenafil citrate

single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Intervention Type DRUG

Other Intervention Names

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Revatio Revatio Revatio

Eligibility Criteria

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Inclusion Criteria

1\) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

2\. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

3\. An informed consent document signed and dated by the subject or a legally acceptable representative.

4\. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.
2. History of febrile illness within 5 days prior to the first dose.
3. A positive urine drug screen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes