[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bioequivalence-study-in-healthy-subjects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bioequivalence-study-in-healthy-subjects":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100644969","phase-1-bioequivalence-study-of-ski-o-703-in-healthy-adults-under-fed-conditions-100644969",false,"NCT07675226","Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions","An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years\n2. Body mass index (weight \\[kg\\] \u002F height2 \\[m\\]2) between 18 and 30 kg\u002Fm2, and body weight not less than 50 kg.\n3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.\n4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents.\n5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Any significant surgical\u002Fmedical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair)\n2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\], cough or fever, or a history of recurrent or chronic infections).\n3. Unable to swallow multiple capsules by mouth.\n4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug.\n5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism.\n6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial.\n7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.\n8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1).\n\n10\\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug.\n\n\\*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide.\n\n14\\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.",true,"ALL","19 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.",[27,28,29],"Bioequivalence Study in Healthy Subjects","Immune Thrombocytopenia (ITP)","Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-07-10",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"Oscotec Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100562216","phase-4-bioequivalence-of-two-formulations-of-parecoxib-in-healthy-volunteers-under-fasting-conditions-100562216","NCT06600282","Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions","A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Parecoxib After Intravenous Bolus of Parecoxib in Healthy Volunteers Under Fasting Conditions","Inclusion Criteria:\n\n1. Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.\n2. Body mass index (BMI) between 18 and 27 kg\u002Fm2 (not inclusive) at the screening visit.\n3. Acceptable medical history and physical examination including:\n\n   * no particular clinically significant abnormalities in Electrocardiogram (ECG) results within six months prior to Period I dosing.\n   * no particular clinical significance in general disease history within two months prior to Period I dosing.\n4. Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes Alanine aminoTransferase (ALT), Aspartate aminoTransferase (AST), gamma-GT, alkaline phosphatase, total bilirubin, albumin, glucose, Blood urea nitrogen (BUN), uric acid, creatinine, total cholesterol, and triglyceride (TG).\n5. Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials, and platelets.\n6. Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin, and protein.\n7. Subjects must use an acceptable method of birth control (e.g. abstinence, condom, intrauterine device, and vasectomy) for the duration of the study.\n8. Have signed the written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.\n2. A clinically significant illness or surgery within four weeks prior to Period I dosing.\n3. History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.\n4. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.\n5. Known or suspected history of drug abuse within lifetime.\n6. History of alcohol addiction or abuse within last five years.\n7. History of allergic response(s) to parecoxib, valdecoxib or any other related drugs.\n8. Evidence of chronic or acute infectious diseases.\n9. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).\n10. Female subjects demonstrating a positive pregnancy screen.\n11. Female subjects who are currently breastfeeding.\n12. Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone, and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone, and ranitidine.\n13. Taking any prescription medications within four weeks or any nonprescription medications (excluding flu and COVID-19 vaccination) within two weeks prior to Period I dosing.\n14. Use of any investigational drug (excluding COVID-19 vaccination) within four weeks prior to Period I dosing.\n15. Use of any COVID-19 vaccine within seven days prior to Period I dosing.\n16. Donating more than 250 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing.\n17. Any other medical reason as determined by the investigator.","20 Years","45 Years",{"count":52,"type":21},14,[54],"PHASE4","A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of parecoxib after intravenous bolus of parecoxib in healthy volunteers under fasting conditions",[57,27],"Post-operative Pain","2024-09-17",{"date":60,"type":34},"2024-09-20",{"date":62,"type":21},"2024-10-01",{"date":64,"type":21},"2024-12-30",{"name":66,"class":41},"Yung Shin Pharm. Ind. Co., Ltd.",1]