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

• Status: Completed
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Drug Research Centre, Cairo, Egypt
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Subject is at least 18-45 years at screening.

• Subject has a Body Mass Index of 18 to 35 kg/m2.

• Subject are non smokers or moderate smokers(not more than 5 cigarettes per day)

• Subject is willing to participate and give their final written consent prior to the commencement of the study procedures

• Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.

• Subject has a normal blood pressure and pulse rate, according to the reference normal ranges

Exclusion Criteria:

• Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.

• Subjects who have taken any medication two weeks preceding of the trial starting date.

• Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.

• Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

• Gastrointestinal diseases.

• Renal diseases.

• Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .

• Pancreatic disease including diabetes.

• Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases

• Hematological disease or pulmonary disease

• Abnormal laboratory values.

• Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.

• Positive HIV test.

• History of or current abuse of drugs, alcohol or solvents.

• Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extra-hepatic tumors

• Autoimmune disorders as Graves disease

• (Central nervous system (CNS) disorders