A prospective, open-label, single-arm clinical study to evaluate the safety andeffectiveness of novel Methylcobalamin nasal spray in the treatment of subjects withvitamin B 12 deficiency.

Dr Banshi Saboo0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1) Vitamin B12 level < 200 pg/mL (148 pmol/L)
•2) Above the age of 18 years
•3) Willing & able to comply with study requirements, e.g. usage of medicines as per
•protocol, willing to adhere to study visit schedule, and willing to fill Patient Diary, as
•indicated by written informed consent provided by the patient.
•4) If women of childbearing potential are recruited they must be non-pregnant
•(supported by a negative urine pregnancy test at screening), and be willing to maintain
•reliable birth control throughout the study.

•1) Lactating Women
•Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any
•component of the study medication.
•2) Patients with any significant nasal pathology, or having chronic nasal symptoms or
•nasal allergies, or upper respiratory tract infections.
•3) Patient using any other nasal medication/device.
•4) Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic
•Patients on treatment with drugs that interfere with vitamin B12 assay.
•5) Participated in any clinical trial within the last 30 days at the time of screening.
•6) Any disorder or condition that in the opinion of the investigator would prohibit study
•participation or affect the study outcome.

发起方

Dr Banshi Saboo