ACTRN12622001391763
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Avance Clinical Pty Ltd
- Enrollment
- 32
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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