A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Prazosin; Serotonin Uptake Inhibitors; Terazosin

Criteria

Inclusion Criteria:

• On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia

• a body mass index between 18 and 35 kg/m², inclusive

• a body weight of not less than 50 kg

• supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive

• and, diastolic blood pressure measurements no higher than 95 mmHg.

Exclusion Criteria:

• History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results

• symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)

• taking a medication that is known to cause orthostatic hypotension, other than terazosin

• and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.