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Pharmacokinetics of amoxicillin clavulanic acid potassium granules (250mg/31.25mg) in Chinese healthy volunters

Pharmacokinetics of amoxicillin clavulanic acid potassium granules (250mg/31.25mg) in Chinese healthy volunters

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003721
Enrollment
Unknown
Registered
2013-10-21
Start date
2013-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Infection

Interventions

Group A:The doses were administered with 250mg/31.25mg for the 1st period, 500mg/62.5mg for the 2nd period, 1000mg/125mg for the 3rd period.
Group B::The doses were administered with 500mg/62.5mg for the 1st period, 1000mg/125mg for the 2nd period, 250mg/31.25mg for the 3rd period.
Group C????1000mg/125mg,????250mg/31.25mg,????500mg/62.5mg:The doses were administered with 1000mg/125mg for the 1st period, 250mg/31.25mg for the 2nd period, 500mg/62.5mg for the 3rd period.

Sponsors

The 1st affiliated hospital, school of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: (1) Healthy, evenly divided between men and women; (2) Aged 18 ~ 40 years old, with a group of subjects no younger than 10 years of age; (3) Body mass index (BMI) in the context of 19-25 kg/m2, [BMI= weight (kg)/height (m2)]; (4) Medical history, physical examination and clinical examination was normal; (5) With no history of major organ disease; (6) With no history of allergy to drugs or any other substances; (7) Non-drug abusers; (8) Non-smoking and alcohol addiction; (9) Without taking drugs nearly two weeks; (10) Communicate well with the researchers and comply with the requirements of the entire study; (11) Informed consent and sign a informed consent form.

Exclusion criteria

Exclusion criteria: (1) Participated in other clinical trials within three months; (2) Donated blood within one month, or plan to donate blood during the trial or within 1 month at the end of the trial; (3) The general examination and blood pressure, heart rate and respiratory conditions did not meet with standards; (4) Any significant clinical disease symptoms during physical examination revealed; (5) Laboratory tests (blood and urine routine, liver and kidney function, ECG and HIV et. al) found hematological abnormalities, heart, liver and kidney dysfunction; (6) Women in menstrual period, pregnancy or lactation; (7) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
AUCtn;Cmax;Tmax;t1/2z;CLz/F;Vz/F;AUCss;Css_min;Cavg;fluctuation%;Accumulation_index;

Countries

China

Contacts

Public ContactJianzhong Shentu

The 1st affiliated hospital, school of Medicine, Zhejiang University

stjz@zju.edu.cn+86 13857111817

Outcome results

None listed

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