A Study to Evaluate the Pharmacokinetics of Tadalafil Administered Once Daily in Japanese and Non-Japanese Subjects With Benign Prostatic Hyperplasia
Abstract
The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH).
The safety of tadalafil will also be studied.
Conditions: Benign Prostatic Hyperplasia.
Primary outcome: Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710; Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710; Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710.
Enrollment: 24 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.
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