Bioequivalence of Roxithromycin Tablets From Two Different ManufacturersPhase 1NCT06798051
Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects
A Phase 1 study testing Roxithromycin tablets 150mg in people with Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
Roxithromycin is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, and pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by Chlamydia… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers
- What is being tested?
- Roxithromycin tablets 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 3 Sep 2019
- 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
- Chinese healthy adults over 18 years old ( including 18 years old ) ;
- Weight : male ≥ 50.0kg, female ≥ 45.0kg and body mass index ( BMI ) :
- 19.0 ~ 26.0kg / m2 ( including boundary value, BMI = weight ( kg ) / height ( m ) 2 ) ;
- Understand and sign the informed consent, volunteer to participate in this study ;
- Be able to communicate well with the researchers and complete the study in accordance with the provisions of the study.
Who cannot join
- There is a history of diseases such as cardiovascular system, respiratory system, digestive system, endocrine system, nervous / mental system, blood and lymphatic system, skeletal muscle system, family genetic disease history and so on;
- Patients who had undergone major surgery within 1 year before screening and were judged not suitable for enrollment by the researchers;
- Comprehensive physical examination, vital signs, 12-lead electrocardiogram, laboratory tests [ including blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy ( only female subjects ) ], etc., suggested that there were abnormalities judged by the researchers as clinically significant ;
- electrolyte potassium < 3.5mmol / L or magnesium < 0.75mmol / L in blood biochemistry ;
- hepatitis B surface antigen ( HBsAg ), hepatitis B e antigen ( HBeAg ), hepatitis C antibody ( HCV-Ab ), human immunodeficiency virus antibody ( HIV-Ab ), treponema pallidum antibody ( TP-Ab ) any test results positive ;
- the existence of researchers judged to have clinical significance of food, drug allergy or other allergic disease history ( asthma, urticaria, eczematous dermatitis, etc. ) or the product and its excipients or its analogues allergy ;
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- Patients who used any drugs that interact with roxithromycin within 30 days before screening ( such as contraceptives, ergotamine/dihydroergotamine, theophylline, anticoagulants, digoxin and other cardiac glycosides, midazolam, cyclosporine, drugs that can prolong QT interval [antidepressants ( such as citalopram ), antiarrhythmic drugs ( such as sotalol, amiodarone ), cisapride, antipsychotics ( such as clozapine
- antibiotics ( such as erythromycin ) ] ;
- who had used any drug within 2 weeks before screening, and was judged by the researcher to be likely to affect the evaluation results of this study ;
- Patients with a history of drug abuse / drug dependence or positive urine screening within 12 months before screening ;
- Patients who drank more than 14g alcohol per week ( 1 unit = 360ml beer or 45ml alcohol with 40 % alcohol or 150ml wine ) within 6 months before screening, or who could not give up drinking during the trial, or who were positive for alcohol breath test ;
- patients who had long-term excessive drinking ( more than 8 cups a day, 1 cup = 250ml ) of tea, coffee or caffeine-containing beverages ;
- Smoking ≥ 3 cigarettes per day within 3 months before screening or those who could not guarantee to give up smoking during the trial ;
- Patients who participated in other drug clinical trials and took research drugs within 3 months before screening ( the last visit time of the last trial was calculated as the start time ) ;
- Screening for blood donation or blood products or massive bleeding > 200ml or 1 unit within the first 3 months, or planning to donate blood or blood components during the study period ;
- Do not agree to avoid the use of tobacco ( including any nicotine-containing smoking cessation products such as nicotine lozenges, nicotine gum ), wine or xanthine, grapefruit, caffeine ( such as coffee, strong tea, chocolate, etc. ) drinks or food ( such as animal liver, mango, pitaya, etc. ), or to avoid strenuous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism, excretion, etc. ;
- Pregnant or lactating women, or those with positive pregnancy test results before the test ; male subjects or female subjects were unwilling to take one or more non-drug contraceptive measures ( such as complete abstinence, contraceptive ring, partner ligation, etc. ) during the trial, or had sperm / egg donation plans or male subjects ( or their partners ), female subjects had fertility plans ( from the signing of informed consent to 3 months after the last administration ) ;
- patients with difficulty in venous blood collection or fainting ;
- tablet swallowing difficulties ;
- those who have special requirements for diet, cannot abide by the diet provided and the corresponding regulations ;
- Subjects who were considered inappropriate to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Trials Center, The Affiliated Hospital of Guizhou Medical University
Guiyang
About this study
Official title: A Single-dose, Fasting, Randomized, Open-label, Two-treatment, Three-period, Partially-replicated, Reference-corrected Crossover Bioequivalence Study of Roxithromycin Tablets in Healthy Subjects
Roxithromycin is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, and pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by Chlamydia trachomatis; and skin and soft tissue infections caused by susceptible bacteria.
The purpose of this study was to evaluate the bioequivalence of roxithromycin tablets from two different manufacturers after fasting administration in healthy subjects and to observe the safety of the test and reference preparations in healthy subjects.
- Being tested
- Roxithromycin tablets 150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxithromycin tablets 150mgDrug
Oral roxithromycin tablets，150mg Once every seven days，One cycle T drug, two cycles R drug
| Study group | Role | What they receive |
|---|---|---|
| A group T-R-R | Experimental | Not described Receives: Drug: Roxithromycin tablets 150mg |
| B group R-T-R | Experimental | Not described Receives: Drug: Roxithromycin tablets 150mg |
| C group R-R-T | Experimental | Not described Receives: Drug: Roxithromycin tablets 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum observed serum or plasma concentration
The with-subject standard deviation of the pharmacokinetic parameter Cmax of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 3 day
area under the serum or plasma concentration-time curve from 0 to t
The with-subject standard deviation of the pharmacokinetic parameter AUC0-t of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 3 day
area under the serum or plasma concentration-time curve from 0 to infinity
The with-subject standard deviation of the pharmacokinetic parameter AUC0- ∞ of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Jun 2019
- Primary completion6 Aug 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence of Roxithromycin Tablets From Two Different ManufacturersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798051
- Sponsor's protocol ID
- KL288-1-BE-01
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Fasting, Randomized, Open-label, Two-treatment, Three-period, Partially-replicated, Reference-corrected Crossover Bioequivalence Study of Roxithromycin Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06798051
- Acronym / sponsor ID
- KL288-1-BE-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 29 Jan 2025 (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.
Roxithromycin is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, and pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by Chlamydia trachomatis; and skin and soft tissue infections caused by susceptible bacteria.
The purpose of this study was to evaluate the bioequivalence of roxithromycin tablets from two different manufacturers after fasting administration in healthy subjects and to observe the safety of the test and reference preparations in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A group T-R-R | Experimental | Drug: Roxithromycin tablets 150mg |
| B group R-T-R | Experimental | Drug: Roxithromycin tablets 150mg |
| C group R-R-T | Experimental | Drug: Roxithromycin tablets 150mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese healthy adults over 18 years old ( including 18 years old ) ;
- Weight : male ≥ 50.0kg, female ≥ 45.0kg and body mass index ( BMI ) :
- 19.0 ~ 26.0kg / m2 ( including boundary value, BMI = weight ( kg ) / height ( m ) 2 ) ;
- Understand and sign the informed consent, volunteer to participate in this study ;
- Be able to communicate well with the researchers and complete the study in accordance with the provisions of the study.
Key exclusion criteria (21 listed)
- There is a history of diseases such as cardiovascular system, respiratory system, digestive system, endocrine system, nervous / mental system, blood and lymphatic system, skeletal muscle system, family genetic disease history and so on;
- Patients who had undergone major surgery within 1 year before screening and were judged not suitable for enrollment by the researchers;
- Comprehensive physical examination, vital signs, 12-lead electrocardiogram, laboratory tests [ including blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy ( only female subjects ) ], etc., suggested that there were abnormalities judged by the researchers as clinically significant ;
- electrolyte potassium < 3.5mmol / L or magnesium < 0.75mmol / L in blood biochemistry ;
- hepatitis B surface antigen ( HBsAg ), hepatitis B e antigen ( HBeAg ), hepatitis C antibody ( HCV-Ab ), human immunodeficiency virus antibody ( HIV-Ab ), treponema pallidum antibody ( TP-Ab ) any test results positive ;
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 |
|---|---|---|
| Roxithromycin tablets 150mgOral roxithromycin tablets，150mg Once every seven days，One cycle T drug, two cycles R drug | Drug | A group T-R-R, B group R-T-R, C group R-R-T |
Primary outcome
maximum observed serum or plasma concentration
Time frame: 3 day
The with-subject standard deviation of the pharmacokinetic parameter Cmax of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
area under the serum or plasma concentration-time curve from 0 to t
Time frame: 3 day
The with-subject standard deviation of the pharmacokinetic parameter AUC0-t of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
area under the serum or plasma concentration-time curve from 0 to infinity
Time frame: 3 day
The with-subject standard deviation of the pharmacokinetic parameter AUC0- ∞ of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
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 29 Jan 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Roxithromycin tablets 150mg in people with Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers, run by The Affiliated Hospital Of Guizhou Medical University 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 5 inclusion and 21 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 29 Jan 2025. 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?
maximum observed serum or plasma concentration (time frame: 3 day). 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 29 Jan 2025.