Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02373046
- Run by
- Lexicon Pharmaceuticals
- People needed
- 30
- Starts
- 2015-02-01
- Last updated by the study team
- 2015-10-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult subjects ≥18 to ≤55 years of age
- Willing and able to provide written informed consent
You may not qualify if…
- 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
Where it is running
- Lexicon Investigational Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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