The superficial varicose veins of the lower limbs
Conditions
Interventions
And 1% of the trial drug group:1% STS injection, single slow intravenous infusion (international standard recommended, needle size 27 G), dose of 1 ml
And 3% of the trial drug group:3% STS injection, single slow intravenous infusion (international standard recommended, needle size 25 G), dose of 2ml
And 1% of the control drug group:1% Fibrovein, single slow intravenous infusion (recommended needle size of 27 G), dose of 1 ml
And 3% of the control drug group:3% Fibrovein, single slow intravenous infusion (recommended needle size of 25 G), dose of 2 ml
Sponsors
The West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 50 years (including the critical value); 2. When the subject was in the standing position, the saphenous vein (large and small saphenous vein) had primary branch or communicating vein reflux >0.5s; and / or ultrasound showed varicose veins with no reflux but visible appearance of the lower limbs; 3. C2 to C5 according to CEAP grade; 4. The standing position of the saphenous vein or its primary branch measured by color Doppler ultrasound, or the diameter of the communicating vein is> 3 mm and =45.0 kg; men weight >=50.0 kg, body mass index within the range of 18.0 to 28.0 kg/m^2 (including critical value); 7. Subjects (including partners) who had effective contraception during the trial and were not birth planned within 3 months of the trial; 8. Voluntary informed consent and compliance with the requirements of the whole study.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any excipients in sodium tetradecyl sulfate or in generic and reference preparations; 2. Subjects with a known history of rapid anaphylaxis or a strong allergic tendency; 3. Subjects with a CEAP score of C1 or C6; 4. Deep vein thrombosis (including active phase), pulmonary embolism, acute superficial vein thrombosis, transient ischemic attack or stroke; hypercoagulation, transitional phlebitis, post-thrombotic syndrome; 5. Subjects with a history of peripheral arterial disease, arterial insufficiency or combined with underlying arterial disease (such as peripheral atherosclerosis, thromboangiitis obliterans); 6. No obvious beat of the posterior tibia or dorsum of the foot, ankle-brachial index of 8 mm or large shallow vein as judged by the investigator, with extensive open traffic branches with deep veins; 9. Color Doppler ultrasound at screening showed severe reflux (> 3.0 s); 10. Skin diseases such as dermatitis and pruritus at the lesion, or varicose veins with local complications; 11. The presence of a right-to-left cardiac shunt, as confirmed by echocardiography, such as a patent foramen ovale; 12. The treatment part of the target vein has previously undergone a surgical operation or intravenous surgery (varicose veins stripping, thermal ablation, chemical ablation, minimally invasive, etc.); 13. Any major surgery (surgery requiring general anesthesia), prolonged hospitalization, or pregnancy within 12 weeks before screening; 14. Subjects who could not walk independently or to pressure as needed, and to cooperate with standing Doppler ultrasound; 15. Subjects with a history of previous thrombotic superficial phlebitis of the target vein; 16. Subjects with a high risk of thrombosis, including current hormonal contraception, hormone replacement therapy, bed braking, malignancy, severe obesity, and recent trauma; 17. Known pelvic or abdominal tumors caused by, or other secondary, superficial varicose veins of the lower limbs (such as congenital venous valve function defects, etc.); 18. Subjects presenting with lymphedema or fibromyalgia; 19. Medical conditions or comorbidities that the investigator considers may interfere with compliance, compromise subject treatment, interfere with safety data judgment, or consider the subject risk to outweigh the benefit, including but not limited to the following: Odema not caused by leg vein disease (such as renal insufficiency, etc.); bronchial asthma; Heart failure, coronary artery disease, and cerebrovascular disease; Active infection, acute cellulitis, tuberculosis, or sepsis; Uncontrolled systemic diseases, such as diabetes mellitus and skin diseases; Severe organic disease. 20. Positive results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or treponema pallidum antibody (TPPA); 21. History of blood donation in the first three months or 400 ml loss of screening period; 22. Have participated in any clinical study, including investigational drugs or medical device, within 4 weeks before screening; 23. Smoking more than 10 cigarettes per day before screening, or being unable to quit during the study period; 24. Drinking more than 14 units of alcohol per week (1 unit =285 ml beer or 25ml spirits or 150ml wine) and not abstinence during the trial; 25. Female subjects a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics of the generic formulation of sodium tetradecyl sulfate (STS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The PK characteristics of the reference preparation Fibrovein?;To evaluate the safety of generic and reference formulations;The PK characteristics of the generic preparation and the reference preparation were compared; | — |
Countries
China
Contacts
Public ContactJichun Zhao/Jia Miao
Vascular Surgery Department / Phase I Clinical Research Laboratory, West China Hospital, Sichuan University
Outcome results
None listed