Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

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Sandoz

Status and phase

Completed
Phase 1

Conditions

Infections

Treatments

Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00875966
AA17045

Details and patient eligibility

About

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion criteria

  • Positive test for HIV or hepatitis B and C
  • Treatment for Drug or alcohol abuse
  • Any other important criteria in the protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 2 patient groups

1
Experimental group
Description:
Azithromycin for oral suspension 200mg/5mL
Treatment:
Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
2
Active Comparator group
Description:
Zithromax (azithromycin for oral suspension) 200mg/5mL
Treatment:
Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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