A Phase 1 interventional study of azithromycin eye drops by essex and azithromycin eye drops in Bacterial Conjunctivitis, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Beijing Tongren Hospital · Phase 1, Interventional, and Treatment
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.
There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's planned enrollment of 56 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once.
Drug: azithromycin eye drops by essex · Drug: azithromycin eye drops
In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once.
Drug: azithromycin eye drops by essex · Drug: azithromycin eye drops
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
Also known as: AzaSite
AUC0-t
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
Cmax
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
AE
compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
SAE
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Plan to share: No
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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin