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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

NCT01247805 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Arterial Hypertention

Interventions

DRUG

sildenafil citrate

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

DRUG

Sildenafil citrate

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

DRUG

sildenafil citrate

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247805 on ClinicalTrials.gov