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A Study to Compare the Oral Absorption of ASP1941 Among Two Types of Tablets

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. Identifier: NCT01972880
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.

Condition or disease Intervention/treatment Phase
Healthy Plasma Concentration of ASP1941 Drug: ASP1941 Phase 1

Detailed Description:

This study is a open-label randomized two-way crossover study. A single dose of two types of ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group, 32 subjects in total).

In case the bioequivalence of the 2 formulations cannot be proved in this study due to insufficient number of subjects, an add-on subject study will be conducted in this clinical trial as needed. Same design and methodology are to be applied to this study and the add-on subject study. The add-on subject study may not be conducted.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: ASP1941 Pharmacokinetic Study - Verification of Bioequivalence Between ASP1941 New Tablets and ASP1941 Conventional Tablets -
Study Start Date : September 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: tablet-1 Drug: ASP1941
Other Name: ipragliflozin

Active Comparator: tablet-2 Drug: ASP1941
Other Name: ipragliflozin

Primary Outcome Measures :
  1. Plasma concentration of unchanged ASP1941 [ Time Frame: Before study drug administration on the administration day (Day 1), and 0.25,0.5,1,1.5,2,2.5,3,4,5,6,8,10,12,24,36,48,72 hours after administration ]

Secondary Outcome Measures :
  1. Safety assessed by vital signs (sitting blood pressure, sitting pulse rate, axillary body temperature), AEs (including subjective symptoms and objective findings), Laboratory tests (hematology, biochemistry, urinalysis) and 12-lead ECGs [ Time Frame: Up to 5 days after each administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body weight (at screening) >=50.0 kg and < 80kg
  • BMI >= 17.6 and < 26.4 (BMI = Weight (kg)/(Height (m))2)
  • Healthy, as judged by the investigator/sub-investigator based on physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital of the period 1 admission to immediately before study drug administration

Exclusion Criteria:

  • Received or scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before the screening or during the period from screening to hospital admission of the period 1 (Day -1).
  • Donated or scheduled to donate more than 400 mL of whole blood within 90 days before the screening, more than 200 mL of whole blood within 30 days before screening, blood components within 14 days before screening, or whole blood or blood components during the period from screening to hospital admission of the period 1 (Day -1).
  • Received or scheduled to receive medications (including OTC drugs) within 7 days before hospital admission of the period 1 (Day -1).
  • A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG at screening or hospital admission of the period 1 (Day -1)
  • Concurrent or previous drug allergies
  • Development of upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before hospital admission of the period1 (Day-1)
  • Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced hepatic disorder, and hepatic function disorder)
  • Concurrent or previous heart disease (e.g., congestive cardiac failure, angina pectoris, and arrhythmia requiring treatment)
  • Concurrent or previous gastrointestinal disease (e.g., peptic ulcer and reflux esophagitis), except for a history of appendicitis
  • Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis), except for a history of renal calculus
  • Concurrent or previous endocrine disease (e.g., hyperthyroidism and blood abnormal growth hormone)
  • Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
  • Concurrent or previous severe ketosis, diabetic coma, or precoma
  • Previous use of ASP1941

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 identifier (NCT number): NCT01972880

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Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Medical Director Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc Identifier: NCT01972880    
Other Study ID Numbers: 1941-CL-7001
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Astellas Pharma Inc:
Open-label design
Additional relevant MeSH terms:
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Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs