Absolute Bioavailability Study With Ipragliflozin

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Bioavailability of Ipragliflozin

Treatments: Drug: Ipragliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611428

2010-023813-77 (EudraCT Number)

1941-CL-0057

Details and patient eligibility

About

A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion criteria

• Any of the liver function tests above the upper limit of normal.
• Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
• A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Ipragliflozin - oral

Experimental group

Description:

open label

Treatment:

Drug: Ipragliflozin

Ipragliflozin - i.v.

Experimental group

Description:

open label

Treatment:

Drug: Ipragliflozin