Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets
- Registration Number
- NCT02373046
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A LX4211 1 × 400-mg LX4211 tablet (fasted conditions) Treatment B LX4211 2 × 200-mg LX4211 tablets (fasted conditions)
- Primary Outcome Measures
Name Time Method AUC Days 1 to 5, Days 9 to 13 Urinary Glucose Excretion (UGE) Day 1, Day 9
- Secondary Outcome Measures
Name Time Method # of Adverse Events Day 1-Day 14
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸Dallas, Texas, United States