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Pharmacokinetic study of dicloxacillin sodium capsule in healthy vonlunteers

Pharmacokinetic study of dicloxacillin sodium capsule in healthy vonlunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003696
Enrollment
Unknown
Registered
2013-10-11
Start date
2013-10-10
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 C:The doses were administered with sequence (1.0g, 2.0g, 0.25g, 0.5g) in four periods.
group A:The doses were administered with sequence (0.25g, 0.5g, 1.0g, 2.0g ) in four periods.
group B:The doses were administered with sequence (0.5g, 1.0g, 2.0g, 0.25g) in four periods.
group D:The doses were administered with sequence (2.0g, 0.25g, 0.5g, 1.0g) in four periods.

Sponsors

The first affiliated hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Healthy male and female volunteers; (2) Aged 18-40 years, 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) Vonlunteers could communicate well with the researchers and comply with the requirements of the entire study; (5) Written informed consent was obtained from all subjects prior to enrolment.

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) subjects had a history or evidence of any clinically significant diseases by direct medical history questioning and physical examination; (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) Subjects had a history of hypersensitivity,allergy, serious adverse drug reaction, especially to penicillin drugs; (8) Smoking, drinking or drug addiction prior to or during the study; (9) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
AUCtn;Cmax;Tmax;t1/2z;fration of unchanged drug excreted in urin;

Secondary

MeasureTime frame
CLz/F;Vz/F;AUCss;Css_min;Cavg;fluctuation%;Accumulation_index;

Countries

China

Contacts

Public ContactJianzhong Shen-tu

The first affiliated hospital, School of Medicine, Zhejiang University

stjz@zju.edu.cn+86 571 87236560

Outcome results

None listed

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