NCT02138773

A Study to Compare How Tamsulosin is Absorbed to the Body After Administration of Two Types of Tamsulosin Formulation Under Fed and Fasted Conditions in Chinese Healthy Subjects

A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule (Tamsulosin Pellet From Meppel Plant and Nishine Plant) Under Fed and Fasted Conditions in Chinese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared.

Detailed description

There will be two studies. One study will be conducted under fed condition, and the other study will be conducted under fasted condition. Each study is a single center, randomized, single dose, open-labeled, cross-over study. Study 1 will be conducted under fed condition: Subjects will undergo screening evaluations to determine their eligibility within 7 days prior to the study enrollment. Subjects will be admitted to the clinical facility in the evening prior to dosing for each period. All subjects will receive tamsulosin formulation-A and formulation-B in one of two randomly assigned treatment sequences at 0.5h after the start of a standard breakfast. There will be a 7-day washout period between each dose. Study 2 will be under fasted condition: A single oral dose of tamsulosin formulation-A or formulation-B will be given to subjects under fasted condition (fasting for at least 10 hours since 20:00PM the night before the administration). Blood will be sampled at the same time point as in Study 1. Also, safety evaluation will be performed at the same selected times throughout the study as in Study 1.

Conditions

• Healthy
• Pharmacokinetics of Tamsulosin Hydrochloride

Interventions

Type	Name	Description
DRUG	Tamsulosin formulation-A	oral
DRUG	Tamsulosin formulation-B	oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-05-15
• Last updated: 2014-07-16

Locations

1 site across 1 country: China