Upper Respiratory Tract InfectionPhase 4NCT06149117

Bioequivalence Study of Azithromycin Capsule and Reference Formulation Sumamed * in Healthy Adult Subjects in China

A Phase 4 study testing test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®" in people with Upper Respiratory Tract Infection and Lower Respiratory Infection, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Main research purpose To investigate the pharmacokinetics of the test preparation azithromycin capsule and the reference preparation azithromycin capsule (Sumamed®) in Chinese healthy adult subjects by single oral administration in fasting state, and to evaluate the bioequivalence of the two preparations by oral… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Upper Respiratory Tract Infection, Lower Respiratory Infection, Skin Infection
What is being tested?: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 16 Nov 2022to 3 Apr 2023
Phase: Phase 4
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

Participants must meet all of the following inclusion criteria to be enrolled in the study:
Before the test, voluntarily sign informed consent, fully understand the test content, process and possible adverse reactions, and be able to complete the study in accordance with the requirements of the test plan;
Chinese male and female subjects aged 18-45 years old (including 18 and 45 years old);
The weight of male subjects is not less than 50.0kg, the weight of female subjects is not less than 45.0kg, the body mass index (BMI = weight/height 2 (kg/m2)), the body mass index is in the range of 19.0~26.0 kg/m2 (including the cut-off value).

Who cannot join

One of the following conditions will be excluded:
(Consultation, systematic inquiry) The study physician considers it inappropriate for participants to have past or present chronic or serious diseases of cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, psychiatric, nervous, gastrointestinal, metabolic and skeletal systems;
Clinically significant abnormalities judged by clinicians during the screening period, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination;
(Check) male QTc interval greater than 450ms, female QTc interval greater than 470ms;
(consultation) past or current epilepsy or a history of seizures;
Patients with a history of cholestatic jaundice/hepatic insufficiency after previous use of azithromycin;

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(consultation) people who have a history of specific allergies (asthma, etc.) or are currently suffering from allergic diseases (urticaria, eczema, etc.), or are allergic to two or more drugs, foods such as milk or pollen, or are known to be allergic to components or analogizes of this drug (such as azithromycin, erythromycin, other macrolides or ketonolactones);
(consultation) have dysphagia or any history of gastrointestinal diseases that affect drug absorption (such as stomach or small intestine resection, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.);
(consultation) patients with any disease that increases the risk of gastrointestinal bleeding (such as acute gastritis or gastric and duodenal ulcers);
(consultation) Patients with venous blood collection difficulties and a history of fainting needles and fainting blood;
(consultation, examination) female subjects who are in pregnancy, breastfeeding or pregnancy test results are positive;
(Consultation) Subjects (including male subjects) who have not taken effective contraception within 14 days before the first dose, or who have a pregnancy, sperm donation or egg donation plan within 6 months after the last dose, see Appendix 2 for specific contraceptive methods;
(examination) Human immunodeficiency virus antibody (screening), hepatitis B virus surface antigen test, hepatitis C virus antibody test, treponema pallidum antibody any test result is positive;
(consultation, examination) have a history of drug abuse within five years, or have used drugs within 3 months before screening, or urine drug screening positive;
(consultation, examination) those who consumed an average of more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine) in the three months prior to screening, or those who could not stop alcohol intake from 24 hours before medication to the completion of the blood sample collection for that cycle, or those who tested positive for alcohol breath;
(Consultation) Those who smoked more than 5 cigarettes per day on average in the 3 months before screening or used e-cigarette products or refused to stop smoking (including e-cigarettes) during check-in;
(Consultation) patients with surgery or severe trauma that the investigator determined would affect drug absorption, distribution, metabolism, or excretion, or who are scheduled to be hospitalized for surgery, dental surgery, or hospitalization during the study period;
Blood donation and/or component blood within 3 months before screening or planned blood donation and/or component blood during the test period, or large blood loss (>400mL, except for female physiological blood loss), or blood transfusion or use of blood products;
Patients who have participated in any drug clinical trials and used drugs within 3 months before screening (consultation);
(Consultation) Those who have taken any drug that alters liver enzyme activity or interacts with azithromycin (such as antacids, ergotamine or dihydroergotamine, fluconazole, efavirenz, nefinavir, etc.) within 28 days before the first dose;
(Consultation) Those who have taken any prescription drugs (including vaccines) within 14 days before the first dose;
(Consultation) Those who have taken any non-prescription drugs, Chinese herbs or health products for the prevention and/or treatment of their own diseases within 14 days prior to the first medication;
(Consultation) 48 hours before the first dose until the end of the study, those who cannot avoid eating a special diet (such as grapefruit and products containing grapefruit components) or have vigorous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
(Consultation) patients who cannot avoid consuming any food or drink rich in caffeine or xanthines (such as coffee, tea, chocolate, cocoa, milk tea, etc.) 48 hours before taking the drug until the end of the study;
Subjects deemed unsuitable by other investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 101149

Other trials in China

About this study

Official title: A Single-center, Open-label, Randomized, Single-dose, Crossover Study to Compare the Equivalence of the Fasting Oral Test Formulation Azithromycin Capsule to Reference Formulation Sumamed *in Healthy Adult Chinese Subjects

Main research purpose

To investigate the pharmacokinetics of the test preparation azithromycin capsule and the reference preparation azithromycin capsule (Sumamed®) in Chinese healthy adult subjects by single oral administration in fasting state, and to evaluate the bioequivalence of the two preparations by oral administration in fasting state.

Secondary research purpose

To investigate the safety of the test preparation azithromycin capsule and the reference preparation "Sumamed®" in healthy subjects.

Read the detailed description

The fasting trial was designed with single-center, open, randomized, single-dose, two-cycle, two-sequence and cross-dosing trials.

Conditions: Upper Respiratory Tract Infection, Lower Respiratory Infection, Skin Infection, Subcutaneous Tissues Infection, Genital Infection
Being tested: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"
Medical subject headings: Respiratory Tract Infections, Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"Drug
Take one capsule orally every cycle(T or R)

Study groups in NCT06149117
Study group	Role	What they receive
test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"	Experimental	TR Receives: Drug: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"
reference product (R) azithromycin capsule "Sumamed®"and test product (T) azithromycin capsule	Experimental	RT Receives: Drug: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
PK parameters comparison between test product azithromycin capsuleand Sumamed®: Cmax
Measured: Pre-dose and after dose 7 days
AUC0-t
PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-t
Measured: Pre-dose and after dose 7 days
AUC0-∞
PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-∞
Measured: Pre-dose and after dose 7 days

Secondary outcomes (4)

Tmax
PK parameters comparison between test product azithromycin capsuleand Sumamed®:Tmax
Measured: Pre-dose and after dose 7 days
t1/2
PK parameters comparison between test product azithromycin capsuleand Sumamed®:t1/2
Measured: Pre-dose and after dose 7 days
λz
PK parameters comparison between test product azithromycin capsuleand Sumamed®:λz
Measured: Pre-dose and after dose 7 days
AUC_%Extrap
PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC_%Extrap
Measured: Pre-dose and after dose 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20223 Apr 2023

First posted28 Nov 2023
Study start16 Nov 2022
Primary completion3 Apr 2023
Study completion3 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Upper Respiratory Tract InfectionStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06149117
Sponsor's protocol ID: I-2022-03
Status last verified: Nov 2023
First submitted: 4 Sep 2023
Last updated: 28 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
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Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
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All Upper Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Randomized, Single-dose, Crossover Study to Compare the Equivalence of the Fasting Oral Test Formulation Azithromycin Capsule to Reference Formulation Sumamed *in Healthy Adult Chinese Subjects
ClinicalTrials.gov ID: NCT06149117
Acronym / sponsor ID: I-2022-03
Conditions: Upper Respiratory Tract Infection, Lower Respiratory Infection, Skin Infection, Subcutaneous Tissues Infection, Genital Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Study start: 16 Nov 2022 (actual)
Primary completion: 3 Apr 2023 (actual)
Study completion: 3 Apr 2023 (actual)
First posted: 28 Nov 2023 (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.

Main research purpose

Secondary research purpose

To investigate the safety of the test preparation azithromycin capsule and the reference preparation "Sumamed®" in healthy subjects.

Detailed description

The fasting trial was designed with single-center, open, randomized, single-dose, two-cycle, two-sequence and cross-dosing trials.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"	Experimental	Drug: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"TR
reference product (R) azithromycin capsule "Sumamed®"and test product (T) azithromycin capsule	Experimental	Drug: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"RT

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants must meet all of the following inclusion criteria to be enrolled in the study:

Key exclusion criteria (25 listed)

One of the following conditions will be excluded:

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
test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"Take one capsule orally every cycle(T or R)	Drug	reference product (R) azithromycin capsule "Sumamed®"and test product (T) azithromycin capsule, test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"

Primary outcome

Cmax
Time frame: Pre-dose and after dose 7 days
PK parameters comparison between test product azithromycin capsuleand Sumamed®: Cmax
AUC0-t
Time frame: Pre-dose and after dose 7 days
PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-t
AUC0-∞
Time frame: Pre-dose and after dose 7 days
PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-∞

4 secondary outcomes

Tmax
Time frame: Pre-dose and after dose 7 days
t1/2
Time frame: Pre-dose and after dose 7 days
λz
Time frame: Pre-dose and after dose 7 days
AUC_%Extrap
Time frame: Pre-dose and after dose 7 days

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 28 Nov 2023.

Related trials for Upper Respiratory Tract Infection

Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Not yet recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection

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?

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 25 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 28 Nov 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Cmax (time frame: Pre-dose and after dose 7 days). 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?

On the ClinicalTrials.gov record for NCT06149117.

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 28 Nov 2023.