Bioequivalence Clinical Trial
Official title:
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release (IR) 1 x (150 mg/500 mg) With Respect to the Metformin IR Tablet (Locally Sourced From Canada [Glucophage, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg and 1 x 100 mg) in Healthy Fed and Fasted Subjects
The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.
This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All the eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will be collected for evaluation of pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study. ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03705533 -
Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
|
Phase 1 | |
| Completed |
NCT04938856 -
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT03646331 -
Bioequivalence of Imeglimin Tablet Formulations
|
Phase 1 | |
| Completed |
NCT04564456 -
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05197517 -
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
|
Phase 1 | |
| Completed |
NCT03702894 -
Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT03018015 -
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|
Phase 1 | |
| Withdrawn |
NCT02894515 -
Bioequivalence Study of Idalopirdine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02206295 -
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
|
Phase 1 | |
| Completed |
NCT01331993 -
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
|
Phase 1 | |
| Completed |
NCT01260805 -
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
|
Phase 1 | |
| Recruiting |
NCT06066112 -
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body
|
Phase 1 | |
| Completed |
NCT05477810 -
Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions
|
Early Phase 1 | |
| Completed |
NCT04546256 -
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05083325 -
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
|
Phase 1 | |
| Completed |
NCT05061901 -
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
| Recruiting |
NCT04138888 -
A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
| Completed |
NCT06124560 -
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
|
Phase 1 | |
| Completed |
NCT03340753 -
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
|
Phase 1 |