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Azithromycin manufactured in China

Phase 1

Bioequivalence | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 21, 2019

Target and mechanism

ModalitySmall molecule

Also known as Azithromycin Tablet manufactured in China

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Azithromycin manufactured in China · 1 trial · 1 indication

Phase 1 1
NCT03353480Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United StatesBioequivalence
COMPLETED66 Analytics
PHASE1COMPLETED
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
Bioequivalence
NCT0335348066
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Study Endpoints

Primary Endpoints

AUC0-72
0-72 hours

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

Cmax
0-72 hours

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

Secondary Endpoints

Adverse Events
Day 1 to Day 32 or early termination, plus at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ReferenceOTHER250mg Azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US
ExperimentalEXPERIMENTAL250mg Azithromycin tablet manufactured at Pfizer Dalian, China

Interventions

NameTypeDescription
Azithromycin Tablet manufactured in ChinaDRUG250 mg Azithromycin Tablet manufactured in China
Azithromycin Tablet manufactured in USDRUG250 mg Azithromycin Tablet manufactured in US
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:China
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