Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

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This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

1 × 400-mg LX4211 tablet (fasted conditions)

Group Type EXPERIMENTAL

LX4211

Intervention Type DRUG

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

LX4211

Intervention Type DRUG

Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9

Treatment B

2 × 200-mg LX4211 tablets (fasted conditions)

Group Type EXPERIMENTAL

LX4211

Intervention Type DRUG

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

LX4211

Intervention Type DRUG

Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9

Interventions

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LX4211

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Intervention Type DRUG

LX4211

Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult subjects ≥18 to ≤55 years of age
* Willing and able to provide written informed consent

Exclusion Criteria

* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211
* History of renal disease, or significantly abnormal kidney function test at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes