NCT03895229

The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An Open-label, One way, Two period Comparative study To Determine The effect of Morning Versus Evening administration of Empagliflozin 10mg on Its Pharmacokinetics And Pharmacodynamics in Healthy Adults

Detailed description

Sixteen(16) healthy subjects will receive a single oral dose of Empagliflozin at the evening(Period I) and after a seven days washout period, the same 16 subjects will receive a single oral dose of Empagliflozin at the morning(Period II). In both Periods(I and II), blood samples will be collected from each volunteer ethylene diamine tetra-acetic acid(KEDTA) containing tubes prior to drug administration then samples will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours(h) after drug administration. These samples will be centrifuged and the plasma harvested and stored at -80°C until assay. Urine samples will be collected over the first 24h after oral administration of the drug with sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.

Conditions

• Diabetes Mellitus
• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG Oral Tablet [Jardiance]	Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-10-19
• Completion: 2018-10-26
• First posted: 2019-03-29
• Last updated: 2019-04-02

Locations

1 site across 1 country: Egypt