NCT02373046

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LX4211	Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9
DRUG	LX4211	Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• First posted: 2015-02-26
• Last updated: 2015-10-02

Locations

1 site across 1 country: United States