NCT06149117

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 4, 2023

Last Update Submit

November 20, 2023

Conditions

Upper Respiratory Tract InfectionLower Respiratory InfectionSkin InfectionSubcutaneous Tissues InfectionGenital Infection

Outcome Measures

Primary Outcomes (3)

  • Cmax

    PK parameters comparison between test product azithromycin capsuleand Sumamed®: Cmax

    Pre-dose and after dose 7 days

  • AUC0-t

    PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-t

    Pre-dose and after dose 7 days

  • AUC0-∞

    PK parameters comparison between test product azithromycin capsuleand Sumamed®:AUC0-∞

    Pre-dose and after dose 7 days

Secondary Outcomes (4)

  • Tmax

    Pre-dose and after dose 7 days

  • t1/2

    Pre-dose and after dose 7 days

  • λz

    Pre-dose and after dose 7 days

  • AUC_%Extrap

    Pre-dose and after dose 7 days

Study Arms (2)

test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"

EXPERIMENTAL

TR

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

Drug: test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"

Interventions

test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"DRUG

Take one capsule orally every cycle(T or R)

reference product (R) azithromycin capsule "Sumamed®"and test product (T) azithromycin capsuletest product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;
  • (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;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCellulitis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

September 4, 2023

First Posted

November 28, 2023

Study Start

November 16, 2022

Primary Completion

April 3, 2023

Study Completion

April 3, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CN(1)