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

Lexicon Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LX4211

Study type

Interventional

Funder types

Industry

Identifiers

NCT02373046

LX4211.117 (Other Identifier)

LX4211.1-117-NRM

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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