Bioequivalence Clinical Trial
Official title:
AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER BARCELONETA, UNITED STATES) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a reference scaled bioequivalence study to support the program and to demonstrate the bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 3-way crossover study will enroll approximately 33 subjects for each condition. The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.
This is a reference scaled bioequivalence study to support a generic consistency evaluation
program, initiated by CFDA in 2016, for the evaluation of quality and efficacy of the
products manufactured in China. The selected strength of 250 mg tablet is the approved
strength. The primary objective is to demonstrate the bioequivalence between the 250 mg
azithromycin tablet manufactured at Pfizer Dalian, China (the localized originator, Test) and
the 250 mg azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US (the
originator, Reference) in healthy Chinese subjects under fasted (Group 1) and fed (Group 2)
conditions. Approximately 33 Chinese healthy subjects will be enrolled for each group.
The primary endpoints are azithromycin area under the serum concentration-time curve from
time zero to 72 hours post-dose (AUC72) and Cmax.
The secondary objective is to evaluate the safety and tolerability of azithromycin
administered as a single oral dose of 250 mg tablet manufactured at Pfizer Dalian, China and
250 mg tablet manufactured at Pfizer Barceloneta, Puerto Rico, US in healthy Chinese subjects
under fasted and fed conditions. And the secondary endpoint is adverse events (AEs). Other
endpoints include Tmax of azithromycin, safety laboratory tests and vital signs.
In each group, subjects will be randomized to one of the 3 treatment sequences. Each
treatment sequence will consist of 3 periods, separated by a washout period of at least 14
days between each period.
On Day 1 of each period in both groups, each subject will be administered investigational
product at approximately 8:00 AM (± 2 hours). Blood samples for the analysis of azithromycin
in serum will be collected at pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 2,
3, 4, 5, 6, 8, 10, 12, 24, 48 and 72 hours post dose in each period. Vital signs, physical
examination, laboratory tests and 12-lead electrocardiogram (ECG) will be performed at
specified times. Tolerability and safety will be assessed for all treatments by monitoring
AEs.
;
| 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 | |
| Withdrawn |
NCT02894515 -
Bioequivalence Study of Idalopirdine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03018015 -
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|
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 |