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

NCT01972880 | Completed Phase 1

• 1 other identifier: 1941-CL-7001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Plasma Concentration of ASP1941

Keywords

Open-label design; Bioequivalence; ASP1941

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of unchanged ASP1941

  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 Outcomes (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

  Up to 5 days after each administration

Study Arms (2)

tablet-1

EXPERIMENTAL

Drug: ASP1941

tablet-2

ACTIVE COMPARATOR

Drug: ASP1941

Interventions

ASP1941 DRUG

Oral

Also known as: ipragliflozin

tablet-1; tablet-2

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Interventions

ipragliflozin

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 31, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

JP (1)