DRKS00023279已完成1 期
A SINGLE CENTER, OPEN-LABEL, CLINICAL STUDY TOEVALUATE THE ABILITY OF DERMAL OPEN FLOW MICROPERFUSION (DOFM) FORBIOEQUIVALENCE TESTING OF TOPICALLY APPLIED DICLOFENAC SODIUM PRODUCTSIN HEALTHY SUBJECTS - FDA02_AIM3
HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Ges.mbH0 个研究点目标入组 24 人开始时间: 2020年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- •1. Healthy, adult volunteers of age 18 to 65 years (both inclusive).
- •2. Males or non-pregnant, non-breast feeding females using adequate contraceptive methods or abstinence.
- •3. Able to read, understand and sign the written informed consent form.
- •4. Willing to follow the protocol requirements and comply with protocol restrictions.
排除标准
- •Subjects must not be enrolled in the study if they meet any of the following criteria:
- •1. Social habits
- •a. Smoker who is not willing to refrain from smoking during the in-house visit.
- •b. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
- •2. Medications: Use of any medications other than hormonal contraceptive, hormone replacement therapy or routine vitamins within the 7 days or 5 half-life periods whichever is longer prior to the initial dose of study medication.
- •3. Diseases: Presence of any clinically relevant acute or chronic disease, which in the investigator´s opinion might jeopardise subject`s safety, evaluation of results or compliance with the protocol.
- •4. Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
- •5. Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator.
- •6. Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
- •7. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
- •8. Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
- •9. Positive HIV test.
- •10. Positive alcohol breath test.
- •11. Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
- •12. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •13. Known hypersensitivity to diclofenac or any components of the drugsa.
- •14. Tattoos or broken and/or damaged skin and/or scarring at the application areas.
- •15. Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
- •16. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
- •17. Recent and/or recurrent historya of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
- •18. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities for 14 days after Visit 2 to ensure good tissue regeneration.
- •19. Not willing to refrain from shaving the planned treatment sites or using skin care products on the planned treatment sites for at least 5 days prior to start of Visit 2.
- •20. Pronounced hairiness on the planned treatment sites that may negatively affect BE testing.
- •21. Known allergy/hypersensitivitya to any of the materials/supplies used during the study.
- •22. Presence of needle phobiaa.
- •23. Increased risk of thrombosis, e.g. personal or first degree relative(s) history of deep vein thrombosisa.
- •24. Not enough space on the thighs for the dOFM probe set-up (minimum length of 24 cm, 3 treatment sites with 4 dOFM probes –see Table 1).
- •a As declared by the subject or as reported in medical records.
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