A Prospective, Open-Label, randomized, Clinical study to compare the efficacy and safety of novel Methylcobalamin Nasal Spray with Sublingual Methylcobalamin Tablet in the treatment of subjects with vitamin B12 deficiency.

Troikaa Pharmaceuticals Limited0 个研究点目标入组 37 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1 Patients of either gender in the age group of 18 years and above.
•2 Vitamin B12 level less than 200 pg/mL.
•3 Willing and able to comply with study requirements, e.g. study drug administration and study visit schedule and willing to fill patient dairy, as indicated by written informed consent provided by the patient.
•4 The female subjects who are of non-childbearing potential (or of childbearing potential, and who have a negative urine pregnancy test at screening and willing to maintain reliable birth control throughout the study) and non-lactating

•1 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 Subjects suspected to have illnesses, where Vitamin B12 supplementation is contraindicated.
•4 Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
•5 Patients on treatment with drugs that interfere with Vitamin B12 assay.
•6 Patient using any other nasal medication/device.
•7 Pregnant and / or Lactating Women
•8 Patients having participated in any clinical trial within last 30 days at the time of screening.
•9 Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.

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