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

July 14, 2014 updated by: Astellas Pharma China, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fed, formulation-A
drug administered at 0.5h after the start of a standard breakfast
Drug: Tamsulosin formulation-A
oral
Other Names:
  • Harnal
EXPERIMENTAL: Fed, formulation-B
drug administered at 0.5h after the start of a standard breakfast
Drug: Tamsulosin formulation-B
oral
Other Names:
  • Harnal
EXPERIMENTAL: Fasted, formulation-A
drug administered under fasted condition (fasting for at least 10 hours)
Drug: Tamsulosin formulation-A
oral
Other Names:
  • Harnal
EXPERIMENTAL: Fasted, formulation-B
drug administered under fasted condition (fasting for at least 10 hours)
Drug: Tamsulosin formulation-B
oral
Other Names:
  • Harnal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma China, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (ESTIMATE)

May 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 617-CL-CN3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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