Pharmacokinetic Evaluation of Empagliflozin

NCT03059056 | Completed Phase 1 FDA Drug

• 1 other identifier: YIRG-2016-01
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Project PI (Principal Investigator): Dr Bassam Mahfouz Ayoub, Ph.D., Lecturer of Pharmaceutical Chemistry, The British University in Egypt. Study Design The proposed study will consider the pharmacokinetic evaluation of empagliflozin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, randomized, one treatment, one period, single dose pharmacokinetic study.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Cmax

  The peak plasma concentration of a drug after administration

  12 Hours

• Tmax

  Time to reach Cmax.

  12 Hours

• Elimination half life

  The time required for the concentration of the drug to reach half of its original value.

  12 Hours

• Elimination rate constant

  The rate at which a drug is removed from the body.

  12 Hours

• Area under the curve

  The integral of the concentration-time curve

  12 Hours

Study Arms (1)

pharmacokinetic evaluation

EXPERIMENTAL

Empagliflozin 25 mg

Drug: Empagliflozin 25mg

Interventions

Empagliflozin 25mg DRUG

Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 22-33 years, Average weight: 77.8 kg, Average BMI: 29.2) will be collected at 0, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 h after administration of Empagliflozin 25 mg

Also known as: Jardiance

pharmacokinetic evaluation

Eligibility Criteria

• Age: 22 Years - 33 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The good health of the human subjects was confirmed by a complete medical history and physical examination.

You may not qualify if:

• Chronic disease

Sponsors & Collaborators

• British University In Egypt: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmaceutical Chemistry

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: February 2, 2017
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share