Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers
NCT06337409 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-04-02
Summary
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
Generic empagliflozin 25 mg film-coated tablets
Empagliflozin 25 mg film-coated tablets
Sponsors & Collaborators
-
International Bio service
lead NETWORK
Principal Investigators
-
Uthai Suvanakoot, Ph. D · International Bio service
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2024-07-05
- Completion
- 2024-07-13
More Related Trials
-
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension
NCT06933355 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood
NCT07133399 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Empagliflozin on Urinary Excretion of Adenosine and Osteocyte Function in Patients With Chronic Kidney Disease
NCT04961931 ·Status: UNKNOWN ·Phase: NA
-
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions
NCT04880993 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF
NCT07169981 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
NCT01867307 ·Status: COMPLETED ·Phase: PHASE2
-
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions
NCT04881006 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
NCT05182840 ·Status: COMPLETED ·Phase: PHASE2
-
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
NCT05262764 ·Status: COMPLETED
-
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
NCT01370005 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes
NCT01276288 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Empagliflozin in NODAT
NCT03642184 ·Status: TERMINATED ·Phase: PHASE4
-
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
NCT01131676 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
NCT03557658 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia
NCT04930627 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers
NCT01877889 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
NCT06260059 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
NCT01748526 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
NCT05374343 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
NCT03152552 ·Status: TERMINATED ·Phase: PHASE2
-
Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI
NCT03591991 ·Status: UNKNOWN ·Phase: NA
-
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
NCT03165240 ·Status: COMPLETED ·Phase: PHASE1
-
Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
NCT03852901 ·Status: COMPLETED ·Phase: PHASE1
-
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
NCT06527846 ·Status: ACTIVE_NOT_RECRUITING
-
Impact of the SGLT2 Inhibitor Empagliflozin on Urinary Supersaturations in Kidney Stone Formers
NCT04911660 ·Status: COMPLETED ·Phase: PHASE2