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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373046

Enrollment

Registered

2015-02-26

Start date

2015-02-28

Completion date

Unknown

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLX4211

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC	Days 1 to 5, Days 9 to 13
Urinary Glucose Excretion (UGE)	Day 1, Day 9

Secondary

Measure	Time frame
# of Adverse Events	Day 1-Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026