PharmacokineticsPhase 1NCT03252067
Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
A Phase 1 study testing azithromycin eyedrop in people with Pharmacokinetics, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- azithromycin eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2017to 31 Dec 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years old, male or female;
- BMI in the range of 19 to 24;
- eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
- Good compliance and voluntarily signed consent.
Who cannot join
- Have eye disease or systemic disease;
- physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
- HBsAg, anti-HCV, anti-HIV and TPPA positive;
- those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
- known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
- need to wear contact lenses during the test;
Show all 11Show fewer
- history of internal surgery or laser surgery history;
- participated in other drug clinical trials in the past three months;
- pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
- mental illness or alcohol, history of drug abuse or inability to collaborate;
- Any other circumstances that the investigators consider are unfit to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Feng Wu, 010-58268486, trdrug@126.com
About this study
Official title: Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.
Read the detailed description
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.
- Conditions
- Pharmacokinetics
- Being tested
- azithromycin eyedrop
- Keywords
- Azithromycin eyedrops, pharmacokinetics, tears
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin eyedropDrug
Tear samples will be collected using the strips.
| Study group | Role | What they receive |
|---|---|---|
| azithromycin eyedrop | Experimental | Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours. Receives: Drug: azithromycin eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum concentration (Cmax)
The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.
Measured: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
area under the curve (AUC)
The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.
Measured: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
Secondary outcomes (1)
AEs
Ocular and systemic adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start2 Aug 2017
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Responsible party
- Principal investigator, Xiuli Zhao, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252067
- Sponsor's protocol ID
- TR-PK-201402
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03252067
- Acronym / sponsor ID
- TR-PK-201402
- Conditions
- Pharmacokinetics
- Keywords
- Azithromycin eyedrops, pharmacokinetics, tears
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 17 Aug 2017 (actual)
- 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.
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.
Detailed description
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azithromycin eyedrop | Experimental | Drug: azithromycin eyedropEach of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 45 years old, male or female;
- BMI in the range of 19 to 24;
- eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
- Good compliance and voluntarily signed consent.
Key exclusion criteria (11 listed)
- Have eye disease or systemic disease;
- physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
- HBsAg, anti-HCV, anti-HIV and TPPA positive;
- those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
- known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
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 eyedropTear samples will be collected using the strips. | Drug | azithromycin eyedrop |
Primary outcome
the maximum concentration (Cmax)
Time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.
area under the curve (AUC)
Time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.
1 secondary outcome
AEs
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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.
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 eyedrop in people with Pharmacokinetics, run by Beijing Tongren Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 17 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wu, Master (010-58268486, trdrug@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the maximum concentration (Cmax) (time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.). The study lists 2 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 17 Aug 2017.