ACTRN12622001391763已完成1 期
Comparative Bioavailability, Pharmacokinetics, Safety and Tolerability of Smartech 2% Sodium Diclofenac Topical Solution and PENNSAID 2% Applied to the Knees of Healthy Male and Female Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Is between 18 – 55 years of age (inclusive) at clinical research unit (CRU) admission and a Human Research Ethical committee (HREC)-approved informed consent has been signed and dated.
- •2. Has a body mass index between 19 to 32 kg/ m2.
- •3. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 1 month prior to first study drug administration and have a negative test for nicotine at the screening visit and at check-in on Day -1.
- •4. Medically healthy without clinically significant (in the opinion of the Investigator) abnormalities at screening and prior to dosing at the timepoints indicated in the Schedule of Assessments (SoA), including:
- •Physical examination without any clinically relevant findings at the discretion of the investigator;
- •Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after at least 5 minutes in a supine or semi-supine position;
- •Heart rate (HR) in the range of 45 to 100 bpm after at least 5 minutes rest in a supine or semi-supine position;
- •Body temperature (tympanic), between 35.5°C and 37.7°C;
- •No clinically significant findings at the discretion of the investigator in serum chemistry, haematology, coagulation and urinalysis tests;
- •Triplicate 12-lead ECG, taken after at least 5 minutes in a supine or semi-supine position, with a QT interval corrected using the Fridericia method (QTcF) less than or equal to 450 msec for males and less than or equal to 470 msec for females and no clinically significant abnormalities
- •5. Female volunteers must:
- •a. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level >30 IU/L at the screening visit), or
- •b. If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug
- •6. Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
- •7. All lab values at Screening and CRU admission fall within local laboratory reference ranges or are designated by the Investigator to be not clinically significant. Repeat tests allowable at discretion of Investigator.
- •8. Agree to abstain from:
- •a. Prescription medication (including herbal products, diet aids and hormone supplements), or dietary supplements and over the counter medications, from 14 days prior to CRU admission through to study completion, except contraception prevention medications
- •9. Agrees to abstain from alcohol 3 days prior to each CRU admission and during the confinement period.
- •10. Agrees to abstain from shaving, waxing or any hair removal technique from the knee area within 7 days of each CRU admission. (laser hair removal 90 days). The use of a hair clipper with guard allowable at any time up to and including check-in Day -1 of each treatment period.
- •11. Agrees to avoid exposure to natural or artificial sunlight on treat
排除标准
- •1. Has a known hypersensitivity to diclofenac sodium, salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- •2. History of asthma (childhood asthma acceptable), urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- •3. Has risk factors for cardiovascular thrombotic events; known cardiovascular disease or risk factors for cardiovascular disease.
- •4. Has had a coronary artery bypass graft surgery within the past 12 months.
- •5. In the opinion of the Investigator, a history of and/or risk factors for serious gastrointestinal events (cholecystectomy and Gilbert’s Syndrome acceptable).
- •6. History of gastric bypass surgery.
- •7. Has any skin condition in the opinion of the Investigator that would prohibit topical application of the IP to the skin around the knee, or impair assessment of the skin, this includes tanning product use within 14 days, tattoos or any permanent cosmetic visual alteration (i.e. cosmetic scarification) in the area of application, current or recent unresolved sunburn.
- •8. Has any open wounds on the knee area, or any irregularities of the skin on the knee area (i.e. post-surgical or excessive scarring), or amount of hair, which in the opinion of the Investigator would:
- •a. impact absorption of the investigational product and/or,
- •b. prevent any AE from being noticed and/or
- •c. in the instance of hair around the knee that the Investigator deems may impact conditions a. and/or b., they may choose to allow the use of a hair clipper with guard at any time up to and including check-in Day -1 of each treatment period.
- •9. Has participated in an investigational research study within the last 30 days, or less than five (5) half-lives of the investigational drug have elapsed prior to CRU admission.
- •10. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration
- •11. Has human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen. . (Note that a sustained hepatitis C virologic response is allowable).
- •12. History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
- •13. Positive drugs of abuse or alcohol breath test results at the screening visit or at check-in (Day -1). Retest allowable at discretion of Investigator.
- •14. Is a current smoker or uses tobacco products, or has a positive nicotine test upon screening or admission to the CRU.
- •15. Creatinine clearance (CrCl) < 80 mL/min calculated using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the upper limit of normal (ULN).
- •16. Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- •17. Liver function tests outside the normal range for bilirubin (tota
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