Pharmacokinetics, Safety, and Tolerability of Intravenous Felbinac Trometamol in Healthy Chinese Volunteers: A First-in-Human Single- and Multiple-Dose Escalation Phase I Study with a Randomized, Double-Blind, Placebo-Controlled Design. Felbinac trometamol, an anti-inflammatory and analgesic drug, has been used to treat immediate postoperative pain. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetics of single or multiple intravenous infusions of felbinac trometamol in healthy Chinese volunteers. A total of 56 healthy subjects were enrolled in a single-ascending dose study (11.78-377.00 mg), meanwhile 36 subjects were enrolled in a multiple-ascending dose study (47.13-188.50 mg). Safety endpoints included treatment-emergent adverse events, vital signs
Rheological and Mechanical Analyses of Felbinac Cataplasms by Using Box–Behnken Design Felbinac, an active pharmaceutical ingredient (API) used clinically for the treatment of osteoarthritis, has poor solubility. Felbinac cataplasm product design was investigated using rheological and mechanical analyses. Experiments using a response surface methodology based on Box⁻Behnken design (BBD ) incorporated three independent variables: the proportions of partially neutralized polyacrylate (NP800), dihydroxyaluminum aminoacetate (DAAA), and felbinac. Statistically significant quadratic models obtained using BBD demonstrated optimal NP-800, DAAA, and felbinac cataplasm proportions of 4.78⁻5.75%, 0.30⁻0.59%, and 0.70⁻0.90%, respectively. Felbinac cataplasms exhibited "gel-like" mechanical property
A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of postoperative pain in gynecology.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery undefined
Safety, Tolerability and Pharmacokinetics of Felbinac Trometamol Eye Drops To evaluate the safety and tolerability of felbinac trometamol eye drops of single-dose, multiple-dose, dose escalation in healthy subjects, for providing the basis for the dose setting in the later clinical study. In the single-center, randomized, double-blind, placebo-controlled, single-dose dose escalation study, 48
A Phase Ⅲ Clinical Study Trial of Felbinac Trometamol Injection in China A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery. undefined
A Phase Ⅱ Clinical Study Trial of Felbinac Trometamol Injection in China A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory phase II clinical trial to evaluating the efficacy and safety of Felbinac Trometamol Injection in the treatment of moderate to severe pain after surgery.Main purpose is preliminary evaluation the effectiveness of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to explore the dosage regimen of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery, and provide data support for later clinical trial. undefined
and edema in rat adjuvant-induced arthritis (AIA) model as compared to other NSAID patches. The AIA model was induced by the injection of Mycobacterium butyricum and rats were treated with a patch (1.0 cm × 0.88 cm) containing each NSAID (SFP, ketoprofen, loxoprofen, diclofenac, felbinac, flurbiprofen, or indomethacin) applied to the paw for 6 h per day for 5 days. The pain threshold was evaluated using
Comparison of the efficacy and tolerability of diclofenac gel (Voltarol Emulgel) and felbinac gel (Traxam) in the treatment of soft tissue injuries. In an observer-blind, randomised study, the efficacy and tolerability of two topical NSAID preparations were assessed in 384 patients with acute soft tissue injuries. The patients were allocated to receive treatment with either diclofenac gel (Voltarol Emulgel) 4 g tds or felbinac gel (Traxam) 4 g tds for three or seven days, depending on the rate of recovery. In every parameter studied (pain at rest, pain on movement, pain on local pressure, swelling, range of movement, bruising, degree of recovery, requirement for rescue analgesics, daily pain levels), diclofenac was found to be more effective at day 3 and day 7, with the single exception
Soft tissue trauma: a randomised controlled trial of the topical application of felbinac, a new NSAID. Two hundred and thirty-one patients with acute soft tissue injuries were treated in a double-blind placebo-controlled study of felbinac (biphenylacetic acid) gel applied three times daily to the injured site. Those treated with felbinac had significantly greater improvement at Day 4 (p less than 0.001) and Day 7 (p less than 0.02) than those who received placebo. Patients' self-assessment diary cards confirmed superiority of the active treatment as early as Day 2 of the study. Local skin reactions were few (three per cent), mild and recovered spontaneously. Felbinac is an effective management for acute soft tissue injuries and because of its topical application may be safer than oral non
[Plasma and tissue concentrations of biphenylacetic acid following 1 week oral fenbufen medication and topical administration of Felbinac gel on the knee joint]. In an randomised study 30 patients were treated during one week before undergoing an elective surgery of the knee joint with 1 or 2 g respectively of 3% Felbinac gel (biphenylacetic acid gel) or oral 300 mg Fenbufen thrice daily of tissue concentrations to plasma concentrations of BPAA was smaller in patients treated with oral administration than in patients treated with topical administration. Therefore a partial direct penetration of Felbinac into the deeper tissue compartments can be assumed. There was no significant difference in plasma-, synovial- or tissue concentrations between the two groups treated with the topical
[Felbinac gel for treatment of localized extra-articular rheumatic diseases--a multicenter, placebo controlled, randomized study]. 281 patients with extra-articular rheumatic disorders (enthesiopathy, bursitis, tendinosis, fibrositis) and moderate or severe localized pain during rest or movement in shoulder, neck, elbow or knee were randomized into groups and treated for 14 days in a double blind study with either 1 g Felbinac Gel 3% (biphenyl acetic acid) three times daily (N = 142) or with the gel formulation only (N = 139). In 50% of the patients treated with Felbinac Gel compared to 29% of the placebo treated patients (p = 0.001), the investigator assessed the global therapeutic success to be good or very good. The magnitude of complaints judged on the basis of a visual analogous scale
[Topical felbinac in therapy of athletic injuries]. In the treatment of acute soft tissue injuries, topical nonsteroidal anti-inflammatory drugs are both highly effective and well tolerated. Target is a monopreparation that meets the demands made on a modern topical agent. The active substance, felbinac, readily, penetrates into the tissue affected and accumulates locally, selectively inhibiting inflammation and alleviating pain. This synoptic report on the clinical trials confirm the significant clinical superiority of felbinac over placebo. As compared with piroxicam, felbinac, is more successful in eliminating symptoms. The rapid alleviation of pain by the topical felbinac results in an improvement in the restriction of mobility and rapid restitution of function. The cooling, nongreasy gel base
Active ultrasound either alone or in combination with other active treatments was compared with placebo interventions including sham ultrasound, no treatment and the following ..
and an in vitro isobologram based on the concentrations of both drugs for changes in the gamma-aminobutyric acid (GABA)-induced current response in Xenopus oocytes injected with mRNA from mouse brains in the presence of NQs and/or NSAIDs. After the administration of enoxacin (ENX) in the presence or absence of felbinac (FLB), ketoprofen (KTP), or flurbiprofen (FRP), a synergistic effect was observed