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

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