MedDataX Logo

Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

NCT ID: NCT00866216

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2003-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions

NCT00865670

Infection
COMPLETED PHASE1

Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg

NCT00650273

Healthy
COMPLETED PHASE1

Azithromycin 600 Mg Tablets, Fasting

NCT00834756

Healthy
COMPLETED PHASE1

Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

NCT06164431

Bioequivalence
COMPLETED PHASE1

To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

NCT02853435

Infections, Bacterial
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Azithromycin Monohydrate 600mg Tablets

Group Type EXPERIMENTAL

Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

Intervention Type DRUG

2

Zithromax (Azithromycin Dihydrate) 600mg Tablets

Group Type ACTIVE_COMPARATOR

Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

Intervention Type DRUG

Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
* Female subjects who are pregnant or lactating
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sandoz Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alan S Marion

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AA02511

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Relative Bioavailability Study in Healthy Subjects
NCT00924911 COMPLETED PHASE1
A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood
NCT06647810 COMPLETED PHASE1
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
NCT00648960 COMPLETED PHASE1
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
NCT01662661 COMPLETED PHASE1
Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation
NCT00867685 COMPLETED PHASE1
A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
NCT01209117 COMPLETED PHASE1
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions
NCT00881738 COMPLETED PHASE1
Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects
NCT02259868 COMPLETED PHASE1
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
NCT00840411 COMPLETED PHASE1
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
NCT00840216 COMPLETED PHASE1
A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations
NCT06996886 COMPLETED PHASE1
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants
NCT05263921 COMPLETED PHASE1
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
NCT05512806 COMPLETED PHASE1
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
NCT02508064 COMPLETED PHASE1
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
NCT00881179 COMPLETED PHASE1
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
NCT04263350 COMPLETED PHASE1
A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants
NCT05571163 COMPLETED PHASE1
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects
NCT02256774 COMPLETED PHASE1
Relative Bioavailability Study With BMS-955176
NCT02095886 COMPLETED PHASE1
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
NCT02183441 COMPLETED PHASE1
A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects
NCT01648179 COMPLETED PHASE1
Bioavailability of ATI-1501 With Taste Test Sub Study
NCT03337126 COMPLETED PHASE1
Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants
NCT05525910 COMPLETED PHASE1
Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers
NCT02257008 COMPLETED PHASE1
Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males
NCT06841926 COMPLETED PHASE1