SHR0302 Tablets ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 3 |
| 97 | 潰瘍性大腸炎 | 1 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05392127 (ClinicalTrials.gov) | July 15, 2022 | 23/5/2022 | A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers | A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers | Rheumatoid Arthritis | Drug: SHR0302 Tablets;Drug: Midazolam Maleate Tablets;Drug: Warfarin Sodium Tablets;Drug: Omeprazole Enteric Capsules;Drug: Vitamin K1 Tablets;Drug: Repaglinide Tablets | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 45 Years | Male | 24 | Phase 1 | China |
| 2 | NCT05404724 (ClinicalTrials.gov) | June 25, 2022 | 31/5/2022 | Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects | Study on the Pharmacokinetic Effects of Single-centered, Open, Single-arm, Fixed-sequence Itraconazole on SHR0302 Tablets in Healthy Subjects | Rheumatoid Arthritis | Drug: itraconazole? SHR0302 tablets | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 45 Years | Male | 14 | Phase 1 | China |
| 3 | NCT03254966 (ClinicalTrials.gov) | November 24, 2017 | 15/8/2017 | Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 70 Years | All | 194 | Phase 2 | China |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001940-86-PL (EUCTR) | 11/09/2021 | 09/08/2021 | A phase 3 Study to Evaluate the Efficacy and Safety of SHR0302 in Ulcerative Colitis. | A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 for Induction, Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHR0302 tablets Product Code: SHR0302 INN or Proposed INN: SHR0302 | Reistone Biopharma Company Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Poland;Ukraine;Georgia;China |