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Food Effect Study For New Formulation

NCT01656798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

sildenafil citrate

2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose

DRUG

sildenafil citrate

2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single 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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Singapore

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 NCT01656798 on ClinicalTrials.gov