[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Egyptian International Pharmaceutical Industries Co\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100632715","phase-1-study-to-determine-the-comparative-pharmacodynamics-of-enoxaparin-sodium-biosimilar-with-that-from-clexane-100632715",false,"NCT07517289","Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That From Clexane","Study Name: (SPRING) Study of Pharmacodynamics and Relative Bioavailability of an Invented National Generic Enoxaparin","Inclusion Criteria:\n\n* Healthy male and female participants aged 21 to 55 years at the time of the first dose administration.\n* Body Mass Index (BMI) between 18.5 and 30 kg\u002Fm², and body weight of at least 45 kg.\n* Participants must have vital signs within the normal range, as defined below, measured at pre-dose:\n* Blood Pressure: Systolic 100-130 mmHg, Diastolic 70-90 mmHg.\n* Pulse Rate: 60-100 beats per minute (bpm).\n* Body Temperature: 36.1-37.2\n\nExclusion Criteria:\n\n* Hypersensitivity to Enoxaparin or any of the formulation excipients\n* Contraindication to enoxaparin or related group of drugs, which includes but not limited to significant bleeding disorders, thrombocytopenia, blood-clothing disorders, and increased risk of bleeding.\n* History or presence of any medical condition or disease according to the opinion of the principal Investigator\n* History or presence of significant alcoholism or drug abuse in the past one year.\n* History or presence of heavy smoking (≥10 cigarettes or consumption of tobacco products and refusal to restrain from smoking or consumption of tobacco products for 48.00 hours before dosing until checkout of the study).\n* History or presence of significant renal, hepatobiliary, or liver impairment; a medical or familial history of seizures; significant asthma, urticaria, or other allergic reactions; or any other significant medical condition as determined by the Principal Investigator or their delegate.\n* History of difficulty with donating blood or difficulty in accessibility of veins\n* Use of any prescribed medication, OTC medicines or herbal medicines during the last two weeks preceding the first dosing\n* Participants who have any food allergy, intolerance, restriction, or special diet during the four weeks before screening\n* Participation in a drug research study within the past 2 months planned day of first dose administration\n* Donation of blood in the past 2 months before screening\n* Refusal to abstain from food (fasting) for at least ten hours before dosing\n* Refusal to abstain from alcohol or methylxanthine-containing beverages\n* Participants with a positive test for HBs-Ag, HIV-Ab, or HCV-Ab\n* Participant with a positive drug abuse test in urine at screening or at the time of check-in\n* Participant with abnormal baseline coagulation parameters, such as prolonged PT (if greater than 1.2 to 1.5 times the ULN of approximately 11 to 15 seconds), aPTT (if greater than 1.5 to 2.5 times the ULN of 25 to 40 seconds), or INR values (is above 1.4) outside the normal reference range.\n\nThis is to minimize bleeding risk and confounding effects on study outcomes.",true,"ALL","21 Years","55 Years",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","An Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar 40mg\u002F0.4ml with that from the Reference IMP, Clexane® (40 mg\u002F0.4ml), Following Single-Dose Administration in Healthy Participants. Test: Enoxaparin Sodium (Enoxaparin Sodium 40mg\u002F0.4ml) manufactured by EIPICO, Egypt. Reference: Clexane (Enoxaparin Sodium 40mg\u002F0.4ml) manufactured by Sanofi Aventis, Egypt. Primary objective:\n\nTo assess biosimilarity between a single dose from the test product versus the reference product in healthy participants\n\nSecondary objective:\n\nTo investigate the safety and tolerability of the formulations. This study is a randomized single-dose, two-way, two-period, two-sequence, crossover biosimilarity study with a washout period of one week after each dosing.A minimum of 21 healthy adult male and female participants from Egyptian population will be enrolled in this study, along with 5 additional participants to account for potential dropouts or withdrawal. 26 Participants plus 1-4 alternates will be admitted to the study. An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration. Withdrawals after study drug administration will not be replaced. All participants will be healthy adults aged (21-55) years, with a BMI within the accepted range of 18.5-30 kg\u002Fm², and will meet the study's selection criteria.",[28,29],"Healthy Participants Study","The Focus of the Study is to Determine the Comparative Pharmacodynamic of Enoxaparin Sodium With That of Clexane in Healthy Human Participants",[31,32,33,34,35,36],"Enoxaparin Sodium","Pharmacodynamics","Clexane","Randomized","Healthy participants","single dose","NOT_YET_RECRUITING","2026-04-01",{"date":40,"type":41},"2026-04-08","ACTUAL",{"date":43,"type":22},"2026-04-30",{"date":45,"type":22},"2026-08",{"name":47,"class":48},"Egyptian International Pharmaceutical Industries Co","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100615726","phase-4-evaluation-of-an-atp-containing-parenteral-vitamin-b-complex-in-patients-with-symptomatic-diabetic-polyneuropathy-100615726","NCT07296354","Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy","Randomized, Double-Blind Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age at time of consent\n2. Able to provide informed consent for study participation.\n3. Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10%\n4. Diagnosed with diabetic polyneuropathy, defined as a Diabetic Neuropathy Symptom (DNS) score ≥ 2, with symptom duration of at least 3 months prior to providing informed consent.\n5. Willingness to comply with study procedures and attend scheduled study visits\n6. Patients should be on a stable antidiabetic medication regimen for 30 days prior to randomization.\n\nExclusion Criteria: -\n\n1. Non-diabetic causes of neuropathy, e.g., alcohol abuse, vitamin B12 deficiency, renal failure, or chemotherapy-induced neuropathy other diseases that causes presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.\n2. Current or recent (within 30 days from screening visit) use of Neuropathic pain treatments, including:\n\n   2.1 Gabapentinoids (gabapentin, pregabalin),\n\n   2.2Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine)\n\n   2.3 Tricyclic antidepressants (e.g., amitriptyline) 2.4 Topical capsaicin preparations 2.5 Carbamazepine, 2.6 Oxcarbazepine, 2.7 Lamotrigine 2.8 topiramate 2.9 other agents for neuropathic pain , Sedatives and anxiolytics (Benzodiazepines, Z-drugs (e.g., zolpidem), Barbiturates, Other B-complex or ATP-containing injectable supplements 2.10 Multivitamins or nutritional supplements 2.11 Pentoxifylline or Naftidrofuryl oxalate, Alpha-lipoic acid or other drug classes indicated for treatment of neuropathic pain.\n3. Severe comorbidities (e.g., malignancy, liver failure, end-stage renal disease, decompensated heart failure)\n4. Pregnancy or breastfeeding\n5. Female patients of childbearing potential not using effective contraception (e.g., oral contraceptives, DMPA, IUD, double barrier, sterilization, or confirmed postmenopausal status)\n6. Known hypersensitivity to any component of the investigational product\n7. Participation in another clinical trial within the past 3 months","18 Years","70 Years",{"count":59,"type":22},200,[61],"PHASE4","Epinosine B Forte ampoule is an intramuscular injectable supplement containing adenosine triphosphate (ATP), Cocarboxylase (vitamin B1 derivative), vitamin B12, and nicotinamide (vitamin B3). It is used to support nerve function, treat B vitamin deficiencies, enhance cellular energy metabolism, and alleviate symptoms of fatigue, neuropathy, and general weakness. Commonly prescribed for conditions like peripheral neuritis and recovery from nerve-related disorders. Side effects are generally mild and may include local injection site reactions or allergic responses. Clinical evaluation of this investigational product may provide valuable evidence for its efficacy in treating diabetic neuropathy where impaired energy metabolism and micronutrient deficits often coexist. Establishing the efficacy and safety of Epinosine B Forte through a structured clinical trial is therefore essential. Demonstrating clinical benefit would not only inform and optimize current treatment protocols for DPN but also support the potential for broader clinical application which includes routine use in diabetic care, integration into treatment guidelines, and possible extension to other neuropathic conditions where metabolic support may play a therapeutic role",[64],"Neuropathic Pain","2025-12-08",{"date":67,"type":41},"2025-12-22",{"date":69,"type":22},"2026-01-10",{"date":71,"type":22},"2029-01-10",{"name":47,"class":48},""]