Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Azithromycin Tablet manufactured in China
Azithromycin manufactured in China · 1 trial · 1 indication
Area under the serum concentration-time profile from time zero to 72 hours post dose based on observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods
Maximum serum concentration among observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose
| Arm | Type | Description |
|---|---|---|
| Reference | OTHER | 250mg Azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US |
| Experimental | EXPERIMENTAL | 250mg Azithromycin tablet manufactured at Pfizer Dalian, China |
| Name | Type | Description |
|---|---|---|
| Azithromycin Tablet manufactured in China | DRUG | 250 mg Azithromycin Tablet manufactured in China |
| Azithromycin Tablet manufactured in US | DRUG | 250 mg Azithromycin Tablet manufactured in US |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: 1. Healthy Chinese male and female subjects, between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detaile...
Azithromycin manufactured in China refers to a China-produced version of the antibiotic azithromycin, a small molecule drug. It was studied by Pfizer, Inc. (NYSE: PFE) in a Phase 1 bioequivalence trial comparing the China-manufactured 250 mg tablet with the United States-manufactured version.
Pfizer, Inc. (NYSE: PFE) is the developer associated with Azithromycin manufactured in China. The company conducted a Phase 1 bioequivalence study of the China-manufactured azithromycin 250 mg tablet.
Azithromycin manufactured in China has been studied in a Phase 1 clinical trial. The trial, NCT03353480, is completed. The drug is not approved for any indication based on the available information; it remains an investigational product evaluated for bioequivalence.
Azithromycin manufactured in China was evaluated in one completed Phase 1 trial, NCT03353480, titled "Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States." The trial enrolled 66 healthy adult volunteers in China and used a randomized, controlled design.
Yes, Azithromycin manufactured in China is also known as Azithromycin Tablet manufactured in China. Both names refer to the same China-manufactured azithromycin 250 mg tablet studied by Pfizer, Inc. (NYSE: PFE) in the Phase 1 bioequivalence trial NCT03353480.