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A Pharmacokinetic Study of Single Dose for Lidocaine Patch in Chinese Healthy Subjects

A Pharmacokinetic Study of Single Dose for Lidocaine Patch in Chinese Healthy Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-14004432
Enrollment
Unknown
Registered
2014-02-28
Start date
2014-02-18
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

Local Anesthesia

Interventions

1:18mg Patch
2:36mg Patch
3:72mg Patch

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 45 years old Chinese healthy subjects, gender parity; 2. Weight 50 kg, or body mass index (BMI) within the scope of the 19-24, body mass index (BMI) = weight (kg)/height 2 (m2); 3. The experiment before the history, physical examination, laboratory projects, and related inspection, testing for all normal or mildly abnormal without clinical significance, clinical doctors judge considered eligible; 4. No tobacco, alcohol and other bad habits; 5. There is no history of drug and food allergy; 6. For three months before the test is not as subjects participating in clinical research, to participate in the test within three months before the blood donors; 7. To take effective contraceptive measures or their spouses do not plan 6 months after birth; 8. Judging by the researchers, to observe the test plan; 9. Voluntarily participate in the clinical trials, understand the research program and to be able to sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. The abnormal physical examination, laboratory examination results and have clinical significance; 2. The cardiovascular, digestive, respiratory, blood, urogenital, and mental nerve illness; 3. There are drugs and other allergies, or known to have allergy medicine components; 4. Use any discharge period long may affect the drug of the present study, or are using any medicine; 5. Skin disease with affect drug tests; 6. Delivery within 2 weeks before taking any special diet (including the dragon fruit, mango, pomelo, and/or xanthine diet, chocolate and caffeinated coffee or tea, or any food or drinks containing caffeine, etc.) or strenuous exercise, or other affect drug absorption, distribution, metabolism and excretion; 7. To inspect and urine drug screen test positive for alcohol breath; 8. Nearly a year as the subjects participated in three times or more than 3 times drug clinical subjects; 3 months prior to the test as the subjects to participate any drug clinical trials, or 3 months once blood donors; 9. The known HIV, HBV, HCV infected with the virus; 10. Did not take effective contraceptive measures or their spouses program gave birth to six months; 11. Pregnant or breastfeeding women, or are pregnant may not acceptable contraceptive methods of women, or positive pregnancy test; 12. The researchers think that compliance is poor, or has any unfavorable factors to participate in the test subjects; 13. The researchers and their family members; 14. Probably because of other reasons that you can't accomplish the subjects of this study.

Design outcomes

Primary

MeasureTime frame
height;weight;BMI;pulse;blood pressure;body temperature;Breathe;ECG;X-ray chest radiograph;alcohol test;Urine Test of drug;

Contacts

Public ContactXinghe Wang

Beijing Shijitan Hospital Capital Medical University

wangxinghe@yahoo.com+86 010-63926401

Outcome results

None listed

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