HealthyPhase 1NCT00830336
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
A Phase 1 study testing Azithromycin and Zithromax® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of… 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 and Zithromax®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2005
- 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
- Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30.
- Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing.
- Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
- The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
Show all 37Show fewer
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
- HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens
- URINALYSIS: by dipstick; full microscopic examination if dipstick positive
- URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
- SERUM PREGNANCY SCREEN (female subjects only)
- If female and:
- Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
- Is postmenopausal for at least 1 year; or
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) Exclusion Criteria
- Subjects with a recent history of drug or alcohol addiction or abuse.
- Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
- Subjects demonstrating a positive drug abuse screen when screened for this study.
- Female subjects demonstrating a positive pregnancy screen.
- Female subjects who are currently breastfeeding.
- Subjects with a history of allergic response(s) to azithromycin or related drugs.
- Subjects with a history of clinically significant allergies including drug allergies.
- Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
- Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
- Subjects who report an intolerance of direct venipuncture.
- Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
- Female subjects who report using implanted or injected hormonal contraceptives (birth control) during the 6 months prior to Period I dosing.
- Female subjects who report using oral hormonal contraceptives (birth control) during the 14 days prior to Period I dosing.
- Subjects who report having difficulty fasting or consuming standardized meals.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.
Read the detailed description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
- Conditions
- Healthy
- Being tested
- Azithromycin, Zithromax®
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Oral Suspension
Zithromax®Drug
Also called Zithromax® for Oral Suspension
Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin (test) | Experimental | Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period Receives: Drug: Azithromycin |
| Zithromax® (reference) | Active comparator | Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period Receives: Drug: Zithromax® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration
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)
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)
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 posted27 Jan 2009 (estimated)
- Study startOct 2005
- Primary completionNov 2005
- Study completionNov 2005
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D Carlson, Pharm. D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830336
- Sponsor's protocol ID
- R05-1375
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2009
- Last updated
- 20 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00830336
- Acronym / sponsor ID
- R05-1375
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 21 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.
Detailed description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin (test) | Experimental | Drug: AzithromycinAzithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period |
| Zithromax® (reference) | Active comparator | Drug: Zithromax®Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (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 (37 listed)
- Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30.
- Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing.
- Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
- The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AzithromycinOral Suspension | Drug | Azithromycin (test) |
| Zithromax®Also: Zithromax® for Oral SuspensionOral Suspension | Drug | Zithromax® (reference) |
Primary outcome
Cmax - Maximum Observed Concentration
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)
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)
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 20 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.
James D Carlson, Pharm. D. principal investigator
PRACS Institute, Ltd.
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 and Zithromax® 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 37 inclusion and 0 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 20 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 21 Jul 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 (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 20 Aug 2024.