HealthyPhase 1NCT00649935
Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
A Phase 1 study testing Azithromycin Tablets 600 mg and Zithromax® Tablets 600 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fed conditions. 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 Tablets 600 mg and Zithromax® Tablets 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
- Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
- Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
- intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- barrier methods containing or used in conjunction with a spermicidal agent, or
- surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
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- Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- postmenopausal with an absence of menses for at least one (1) year, or
- bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- total hysterectomy
- During the course of the study, from study screen until study exit, all men and women of childbearing potential must use a spermicide-containing barrier method of contraception in addition to their current contraceptive device. This requirement should be documented in the informed consent form.
- 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Who cannot join
- 1. Institutionalized subjects will not be used. 2. Social Habits:
- Use of any tobacco products within one year prior to dosing.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
- A positive test for any drug included in the urine drug screen.
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- History of drug and/or alcohol abuse. 3. Medications:
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- Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
- Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- 4. Diseases:
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- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, hepatitis B, or hepatitis C test. 5. Abnormal and clinically significant laboratory test results:
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- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- 8. Allergy or hypersensitivity to azithromycin, any of the inactive ingredients, or other related products, such as erythromycin or any macrolide antibiotic.
- 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendle International Inc.
Morgantown, West Virginia, 26505
About this study
Official title: Single-Dose Fed In Vivo Bioequivalence Study of Azithromycin Tablets (600 mg; Mylan) to Zithromax® Tablets (600 mg; Pfizer) in Healthy Volunteers
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fed conditions.
- Conditions
- Healthy
- Being tested
- Azithromycin Tablets 600 mg, Zithromax® Tablets 600 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Tablets 600 mgDrug
600mg, single dose fed
Zithromax® Tablets 600 mgDrug
600mg, single dose fed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Azithromycin Tablets 600 mg Receives: Drug: Azithromycin Tablets 600 mg |
| 2 | Active comparator | Zithromax® Tablets 600 mg Receives: Drug: Zithromax® Tablets 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMay 2005
- Primary completionMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dorian Williams, M.D., Principal investigator, Kendle International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649935
- Sponsor's protocol ID
- AZIT-04101
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fed In Vivo Bioequivalence Study of Azithromycin Tablets (600 mg; Mylan) to Zithromax® Tablets (600 mg; Pfizer) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00649935
- Acronym / sponsor ID
- AZIT-04101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- May 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin Tablets 600 mgAzithromycin Tablets 600 mg |
| 2 | Active comparator | Drug: Zithromax® Tablets 600 mgZithromax® Tablets 600 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
- 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Key exclusion criteria (23 listed)
- 1. Institutionalized subjects will not be used. 2. Social Habits:
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- 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
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 Tablets 600 mg600mg, single dose fed | Drug | 1 |
| Zithromax® Tablets 600 mg600mg, single dose fed | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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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.
Dorian Williams, M.D. principal investigator
Kendle International Inc.
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 Tablets 600 mg and Zithromax® Tablets 600 mg in people with Healthy, run by Mylan Pharmaceuticals Inc 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 13 inclusion and 23 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 24 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bioequivalence (time frame: within 30 days). 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 24 Apr 2024.