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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138773
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Pharmacokinetics of Tamsulosin Hydrochloride Drug: Tamsulosin formulation-A Drug: Tamsulosin formulation-B Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


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 Name: Harnal

Experimental: Fed, formulation-B
drug administered at 0.5h after the start of a standard breakfast
Drug: Tamsulosin formulation-B
oral
Other Name: Harnal

Experimental: Fasted, formulation-A
drug administered under fasted condition (fasting for at least 10 hours)
Drug: Tamsulosin formulation-A
oral
Other Name: Harnal

Experimental: Fasted, formulation-B
drug administered under fasted condition (fasting for at least 10 hours)
Drug: Tamsulosin formulation-B
oral
Other Name: Harnal




Primary Outcome Measures :
  1. 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.

  2. Pharmacokinetic parameter of tamsulosin (Cmax) [ Time Frame: up to 72 hr after administration ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138773


Locations
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China
Shanghai, China
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
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Study Director: Medical Director Astellas Pharma Inc
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Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT02138773    
Other Study ID Numbers: 617-CL-CN3
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
prolonged release formulation
adrenergic blocker
Bioequivalence
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents