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A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin

NCT01366664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-10-07

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.

Conditions

  • Ejaculation

Interventions

DRUG

Treatment sequence 2

Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days)

DRUG

Treatment sequence 1

Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days)

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

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 NCT01366664 on ClinicalTrials.gov