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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:February 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female Subjects

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.


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
We found this trial at
1
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Lexicon Investigational Site
Dallas, Texas 75230
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Dallas, TX
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