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

Viatris

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertention

Treatments: Drug: Sildenafil citrate; Drug: sildenafil citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247805

EudraCT 2010-023521-38

A1481293

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Treatment A

Experimental group

Description:

Revatio: 1 x 20 mg IR oral tablet.

Treatment:

Drug: sildenafil citrate

Drug: sildenafil citrate

Treatment B

Experimental group

Description:

2 x 10 mg sildenafil citrate IR oral tablet.

Treatment:

Drug: Sildenafil citrate

Treatment C

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate

Drug: sildenafil citrate