CTRI/2019/11/022045招募中3 期
A Phase III Study to Evaluate the Safety and Pharmacokinetics of MethylcobalaminNasal Spray, 500μg (Torrent Pharmaceuticals) and Compare the Efficacy ofMethylcobalamin Nasal Spray, 500μg (Torrent Pharmaceuticals) with NasoB12, 500μg(Troikaa Pharmaceuticals)
Torrent Pharamceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Part A Inclusion Criteria
- •1. Male or female subjects of 18-45 years of age
- •2. Subject voluntarily give written informed consent to participate in the study.
- •Part B Inclusion Criteria
- •1. Male or female patients of 18-65 years of age
- •2. Patient with serum vitamin B12 levels <200pg/mL
- •3. Patient voluntarily give written informed consent to participate in the study
排除标准
- •Part A:Exclusion Criteria
- •1. Subject with a history of hypersensitivity to intranasal administration of vitamin B12 or its excipients or any intranasal preparations.
- •2. Subject who have taken any medication by intranasal route or have used any vitamin supplement within the past 72 hours prior to screening.
- •3. History of consumption of vitamin supplements i.e. as prescribed medication in the last 14 Days or over-the-counter medication/ herbal remedies in the last 7 Days prior to screening. Subjects currently on treatment with drugs, which
- •interfere with folate or folic acid metabolism and serum vitamin B12 assay (e.g., cholestyramine, methotrexate, pyrimethamine,
- •proton pump inhibitors, trimethoprim, etc.)
- •4. Subject with clinically significant abnormal nasal or respiratory tract conditions, for example, atrophic rhinitis, nasal polyp,
- •upper respiratory tract infection etc. which may alter the absorption of the study investigational product.
- •5. Subject having any clinically significant medical illness that would compromise safety of the subject or study outcome/serum vitamin B12 levels as per investigator opinion
- •6. Subjects with liver enzymes (Alanine
- •transaminase, Aspartate transaminase, Alkaline phosphatase) > 2.5X the upper limit of normal value (ULN) or total bilirubin >1.5X of ULN or serum creatinine >1.5X of ULN at screening and considered clinically significant by the investigator.
- •7. History of alcohol or drug abuse or tobacco sniffing.
- •8. Subjects with known cases of haemoglobinopathies (e.g history of thalessemia minor/major, sickle cell anemia etc.).
- •9. Subject with clinically abnormal findings on physical examination, vital signs, electrocardiogram and laboratoryinvestigations at screening
- •10. Subjects positive for Hepatitis B surface antigen (HBsAg),Hepatitis C antibody and human immunodeficiency virus (HIV)antibody test.
- •11. Subject with positive breath-alcohol test at enrolment.
- •12. Subject with positive opiate, tetrahydrocannabinol (THC),amphetamine, barbiturates, benzodiazepines or cocaine on
- •urine test at enrolment or known active alcohol abuse within past 6 months
- •13. Pregnant or lactating women.
- •14. In the opinion of the investigator, subject is either unable to cooperate or unlikely to adhere with any study procedure
- •15. Subjects who have participated in any other investigational drug trial within the past 3 months prior to screening.
- •Part B:Exclusion Criteria
- •1. Patients with a history of hypersensitivity to intranasal administration of vitamin B12 or its excipients or any intranasal preparations.
- •2. Patients who have taken any medication by intranasal route or have used any vitamin supplement within the past 72 hours prior to screening.
- •3. History of consumption of vitamin supplements i.e. as prescribed medication in the last 14 Days or over-the-counter medication/ herbal remedies in the last 7 Days prior to screening. Patients currently on treatment with drugs, which
- •interfere with folate or folic acid metabolism and serum vitamin B12 assay (e.g., cholestyramine, methotrexate, pyrimethamine,
- •proton pump inhibitors, trimethoprim, etc.)
- •4. Patients with clinically significant abnormal nasal or respiratory tract conditions, for example, atrophic rhinitis, nasal polyp,upper respiratory tract infection etc. which may al
研究者
相似试验
进行中（未招募）
1 期
A safety and pharmacokinetic study of oral berotralstat for HAE attacks in pediatric patientsEUCTR2021-005932-50-ATBioCryst Pharmaceuticals, Inc.30
招募中
1 期
A safety and pharmacokinetic study of oral berotralstat for HAE attacks in pediatric patientsHereditary Angioedema (HAE)MedDRA version: 23.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-005932-50-DEBioCryst Pharmaceuticals, Inc.30
招募中
1 期
A safety and pharmacokinetic study of oral berotralstat for HAE attacks in pediatric patientsHereditary Angioedema (HAE)MedDRA version: 23.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-005932-50-PLBioCryst Pharmaceuticals, Inc.20
进行中（未招募）
1 期
A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseModerately to Severely Active Crohn's DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-004225-24-Outside-EU/EEAJanssen-Cilag International NV
进行中（未招募）
1 期
A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseModerately to Severely Active Crohn's DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-004225-24-BEJanssen-Cilag International NV90