Healthy VolunteersPhase 1NCT00879983
An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
A Phase 1 study testing azithromycin (Zithromax) in people with Healthy Volunteers, run by Pfizer at 1 site in China.
Trial summary
The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- azithromycin (Zithromax)
- 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 siteChina
- Study dates
- May 2009to Jul 2009
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers.
- Male.
- 18-45 years old.
- BMI 17.5-30.5 kg/m2.
Who cannot join
- Alcohol, drug, smoke user.
- Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
- Severe medical or psychiatric condition or laboratory abnormality.
- Blood donation.
- 12-ECG abnormal.
- Treatment with study drug; clinically significant.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.
- Conditions
- Healthy Volunteers
- Being tested
- azithromycin (Zithromax)
- Keywords
- azithromycin, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin (Zithromax)Drug
Also called Zithromax
- a single dose of azithromycin ER 2g
- 3-day regimen of azithromycin tablet 500mg
azithromycin (Zithromax)Drug
Also called Zithromax
- 3-day regimen of azithromycin tablet 500mg
- a single dose of azithromycin ER 2g
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet. Receives: Drug: azithromycin (Zithromax) |
| Group 2 | Other | Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER . Receives: Drug: azithromycin (Zithromax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC inf (if data permit) and AUC last of azithromycin
Measured: 2 months
Secondary outcomes (2)
AUC 24, Cmax, Tmax, t1/2 of azithromycin
Measured: 2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879983
- Sponsor's protocol ID
- A0661179
- Status last verified
- Jun 2010
- First submitted
- 10 Apr 2009
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00879983
- Acronym / sponsor ID
- A0661179
- Conditions
- Healthy Volunteers
- Keywords
- azithromycin, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Apr 2009 (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 purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: azithromycin (Zithromax)Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet. |
| Group 2 | Other | Drug: azithromycin (Zithromax)Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers.
- Male.
- 18-45 years old.
- BMI 17.5-30.5 kg/m2.
Key exclusion criteria (6 listed)
- Alcohol, drug, smoke user.
- Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
- Severe medical or psychiatric condition or laboratory abnormality.
- Blood donation.
- 12-ECG abnormal.
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 (Zithromax)Also: Zithromax1. a single dose of azithromycin ER 2g 2. 3-day regimen of azithromycin tablet 500mg | Drug | Group 1 |
| azithromycin (Zithromax)Also: Zithromax1. 3-day regimen of azithromycin tablet 500mg 2. a single dose of azithromycin ER 2g | Drug | Group 2 |
Primary outcome
AUC inf (if data permit) and AUC last of azithromycin
Time frame: 2 months
2 secondary outcomes
AUC 24, Cmax, Tmax, t1/2 of azithromycin
Time frame: 2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.
Time frame: 2 months
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 14 Jun 2010.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
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 (Zithromax) in people with Healthy Volunteers, run by Pfizer at 1 site in China.
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 4 inclusion and 6 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 14 Jun 2010. 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 China. 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?
AUC inf (if data permit) and AUC last of azithromycin (time frame: 2 months). 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 14 Jun 2010.