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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy, Pharmacokinetics of Tamsulosin Hydrochloride

Intervention / Treatment
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* Drug: Tamsulosin formulation-A
* Drug: Tamsulosin formulation-B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fed, formulation-A<br>drug administered at 0.5h after the start of a standard breakfast | Drug: Tamsulosin formulation-A<br>* oral<br>* Other names: Harnal;|
| Experimental: Fed, formulation-B<br>drug administered at 0.5h after the start of a standard breakfast | Drug: Tamsulosin formulation-B<br>* oral<br>* Other names: Harnal;|
| Experimental: Fasted, formulation-A<br>drug administered under fasted condition (fasting for at least 10 hours) | Drug: Tamsulosin formulation-A<br>* oral<br>* Other names: Harnal;|
| Experimental: Fasted, formulation-B<br>drug administered under fasted condition (fasting for at least 10 hours) | Drug: Tamsulosin formulation-B<br>* oral<br>* Other names: Harnal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of tamsulosin (AUC0-t) | AUC0-t will be calculated according to the linear trapezoidal rule. | up to 72 hr after administration | 
| Pharmacokinetic parameter of tamsulosin (Cmax) |  | up to 72 hr after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of tamsulosin (AUC0-∞) |  | up to 72 hr after administration | 
| Pharmacokinetic parameter of tamsulosin (Tmax) |  | up to 72 hr after administration | 
| Pharmacokinetic parameter of tamsulosin (T1/2) |  | up to 72 hr after administration | 
| Safety evaluated by physical examinations, vital signs, electrocardiograms, laboratory assessments, and adverse events. |  | up to 72 hr after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged release formulation, adrenergic blocker, Bioequivalence