Azithromycin dry suspension 0.1g Bioequivalence test in fasting state of randomized, open, two-cycle, double-cross healthy subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039086

Enrollment

Unknown

Registered

2020-10-16

Start date

2020-10-21

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-infection

Interventions

Group 1:T-R

Group 2:R-T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who signed informed consent before the trial; 2. The subjects (including their partners) had no pregnancy plan and voluntarily took effective contraceptive measures from 2 weeks before self-sufficiency to 3 months after the last study drug administration; 3. Male and female subjects aged 18-65 years.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to azithromycin, erythromycin, other macrolides or ketolides; 2. Blood donation or massive blood loss (> 400 ml) in the first three months of screening; 3. Patients who took any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days prior to screening; 4. Female subjects were in lactation or serum pregnancy during the screening period or during the test; 5. Patients considered unsuitable for the trial by the researchers.

Design outcomes

Primary

Measure	Time frame
Cmax;AUC0-t;AUC0-8;	—

Countries

China

Contacts

Public ContactGuocheng Zhang

The First Hospital of Jilin University

13844085212@163.com+86 13844085212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026