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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• Body Mass Index (BMI=weight (kg)/height(m)2) between 19 and 24 (included)

• Body weight no less than 50 kg

• Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations

Exclusion Criteria:

• Subject receiving drug treatment (including OTC) within 4 weeks prior to the first administration

• Subject with a known or suspected history of allergic condition and/or hypersensitivity to Tamsulosin, any excipients in the drug product or drugs of the same class

• Existing cardiac, haematological, hepatic, renal, gastrointestinal or any other acute or chronic disease and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics

• Subject with symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20mmHg within two minutes when changing from the supine to the standing position

• Subject with sitting DBP<60mmHg or >90mmHg, and/or SBP<90mmHg or>140mmHg, and/or pulse rate (PR) <40/min or >90/min, and/or axilla temperature >37℃ or <35℃ within the screen period

• Subject with a previous history of drug abuse or subject showing any degree of drug abuse within 3 months prior to the present study

• Subject with a blood donation or other plasma loss of more than 200mL or received a transfusion of any blood or blood products within 3 months prior to the start of the present study

• Subject with a treatment of plasma exchange within 4 weeks prior to the present study

• Subject participated in any other study within 3 months prior to the present study, or participated in more than 3 studies during the last 12 months prior to the start of the present study

• Subject with HBs-Ag, HCV-Ab or HIV-Ab

• Subject with a partner wish to become pregnant during the present study period and 30 days after the study

• Subject is mentally or physically disabled