ISRCTN14847288已完成1 期
Single-way open label phase I study to evaluate the amount of ketoprofen remaining in the oral cavity and ketoprofen salivary concentration after mouthwash rinse with OKI gola® 1.6% collutorio in healthy volunteers of both sexes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Sex and age: men/women, 18-55 years old inclusive
- •3. Body Mass Index (BMI): 18.5-30 kg/m² inclusive
- •4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89
- •mmHg, pulse rate 50-90 bpm and body temperature 35.5-37.5° C, measured after 5 min at rest in the sitting position
- •5. Full comprehension: ability to comprehend the full nature and purpose of the study, including
- •possible risks and side effects; ability to co-operate with the investigator and to comply with the
- •requirements of the study
- •6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
- •6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- •6.3. A male sexual partner who agrees to use a male condom with spermicide
- •6.4. A sterile sexual partner
- •Women of non-child-bearing potential or in post-menopausal status for at least 1 year are admitted.
- •For all women, pregnancy test result must be negative at screening.
排除标准
- •1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- •2. Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen lysine salt or derivatives) and/or formulations' ingredients; known hypersensitivity to non-steroidal anti-inflammatory drugs; history of hypersensitivity to drugs (in particular to ketoprofen) or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- •3. Diseases: significant history of renal, hepatic, gastrointestinal, respiratory, skin, haematological, endocrine, neurological or cardiovascular diseases that may interfere with the aim of the study; mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the investigator’s opinion
- •4. Medications: medications, including over the counter drugs (in particular non-steroidal anti-inflammatory drugs), mouthwashes, oral rinses, herbal remedies and food supplements taken 14 days before the start of the study (in any case at least 5 times the half-life of the drug or a minimum of 14 days, whichever is longer), with the exception of paracetamol. Hormonal contraceptives and hormonal replacement therapy for women are allowed
- •5. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- •6. Blood donation: blood donations for 3 months before this study
- •7. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for women and >2 drinks/day for men), caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day)
- •8. SARS-CoV-2 test: positive SARS-CoV-2 test on day -3 or -2
- •9. Virology: known positive test of Hepatitis B (HBs antigen), Hepatitis C (HCV antibodies), HIV 1/2 (HIV Antigen/Antibodies combo)
- •10. Drug test: positive result at the drug test at screening
- •11. Alcohol test: positive alcohol breath test at screening or day -1
- •12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; vegans
- •13. Pregnancy (women only): positive or missing pregnancy test at screening or day -1; pregnant or lactating women.
研究者
相似试验
已完成
1 期
A first-in-human clinical trial to assess the overall safety and immune response with Typhoid conjugate vaccine of BE, against Typhoid disease in 18-45 year-old healthy adult male volunteers.CTRI/2018/03/012558Biological ELimited30
招募中
1 期
[M24-427]ABBV-400 in Select Advanced Solid Tumor IndicationsHCC, PDAC, BTC, ESCC, BC, HNSCCJPRN-jRCT2031230534Yamagishi Chika220
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the LAVA-051 antibody in patients with chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemiaCD1d-positive relapsed/refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)EUCTR2020-004583-26-ESAVA Therapeutics B.V.102
招募中
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the LAVA-051 antibody in patients with chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemiaRelapsed/refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)EUCTR2020-004583-26-FRAVA Therapeutics B.V.102
进行中（未招募）
1 期
A dose escalation trial to assess the safety and tolerability of multiple doses of the LAVA-051 antibody in patients with chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemiaRelapsed/refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML)EUCTR2020-004583-26-NLAVA Therapeutics N.V.114