HealthyPhase 1NCT00834132
Azithromycin 600 Mg Tablets, Fed
A Phase 1 study testing Azithromycin 600 mg Tablet and Zithromax® 600 mg Tablet in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 24 adult subjects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Azithromycin 600 mg Tablet and Zithromax® 600 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Aug 2002
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex:Non-smoking Male or Female; similar proportions of each preferred.
- Age: At least 18 years.
- Weight: BMI less than 30.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Laboratory Tests: hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in. Laboratory values which are greater than ± 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
- Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- Subjects must read and sign the Consent Form.
Who cannot join
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study:
- History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of treatment for asthma within the past five (5) years.
- History of treatment for any gastrointestinal disorder within the past five (5) years.
Show all 16Show fewer
- History of hepatic function impairment.
- Females who are pregnant or lactating.
- History of hypersensitivity to azithromycin, erythromycin, or any macrolide antibacterial agent.
- Conditions upon screening which might contraindicate or require that caution be used in the administration of azithromycin, including:
- Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50 mmHg.
- Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
- Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) At least three (4) consecutive months of abstinence is required.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301
About this study
Official title: A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 24 Fed, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 24 adult subjects under fed conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Azithromycin 600 mg Tablet, Zithromax® 600 mg Tablet
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 600 mg TabletDrug
1 x 600mg, single-dose fed
Zithromax® 600 mg TabletDrug
1 x 600mg, single-dose fed
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period Receives: Drug: Azithromycin 600 mg Tablet |
| Zithromax® | Active comparator | Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period Receives: Drug: Zithromax® 600 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration - Azithromycin in Plasma
Bioequivalence based on Cmax
Measured: Blood samples collected over 168 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 168 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 168 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJul 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Azber Ansar, M.D., Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834132
- Sponsor's protocol ID
- 02184
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2009
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 24 Fed, Healthy, Adult Subjects
- ClinicalTrials.gov ID
- NCT00834132
- Acronym / sponsor ID
- 02184
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 24 adult subjects under fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Azithromycin 600 mg TabletAzithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period |
| Zithromax® | Active comparator | Drug: Zithromax® 600 mg TabletZithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sex:Non-smoking Male or Female; similar proportions of each preferred.
- Age: At least 18 years.
- Weight: BMI less than 30.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Subjects must read and sign the Consent Form.
Key exclusion criteria (16 listed)
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study:
- Conditions upon screening which might contraindicate or require that caution be used in the administration of azithromycin, including:
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin 600 mg Tablet1 x 600mg, single-dose fed | Drug | Azithromycin |
| Zithromax® 600 mg Tablet1 x 600mg, single-dose fed | Drug | Zithromax® |
Primary outcome
Cmax - Maximum Observed Concentration - Azithromycin in Plasma
Time frame: Blood samples collected over 168 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma
Time frame: Blood samples collected over 168 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma
Time frame: Blood samples collected over 168 hour period
Bioequivalence based on AUC0-t
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azber Ansar, M.D. principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin 600 mg Tablet and Zithromax® 600 mg Tablet in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax - Maximum Observed Concentration - Azithromycin in Plasma (time frame: Blood samples collected over 168 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.