None listed
Conditions
Interventions
Intervention1: Mecobalamin Nasal Spray 500 mcg/ 0.1 mL: Manufactured by: Troikaa Pharmaceuticals Ltd.
Dose: one spray of 0.05 ml in each nostril
Control Intervention1: Methycobal injection: Mecobalami
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Subjects should be in the range of 18 â?? 45 years of age. ii. BMI according to Body Mass Index (BMI) table (Appendix A)(i.e.Kg/m2 Range 18.5 to 24.9. iii. Subject with serum total B12 level range of 200 pg/mL to 900 pg/mL. iv. Subjects with normal findings as determined by Baseline history, Physical Examination and Vital Signs (Blood Pressure, Pulse Rate, Respiratory Rate and Axillary Temperature). v. Subjects with normal/ not significant laboratory values as determined by hematological tests, biochemistry, urine analysis and ECG in correlation with clinical findings. vi. Willingness to follow the protocol requirement as evidenced by written informed consent. vii. Agreeing to, not using or conforming to not having used any medication (prescription and over the counter), including vitamins and minerals for 15 days prior to study & during the course of the study. viii. No history or presence of significant alcoholism. ix. No history of drug abuse. x. Non-smokers, ex smokers and moderate smokers will be included.â??Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who completely stopped smoking for at least 3 months. xi. All female subjects having negative urine pregnancy test prior to enrolling into the study. All female subjects who are of child bearing potential or those within the first two years of the onset of menopausal syndrome using acceptable methods of birth control. Acceptable birth control methods include Barrier methods such as diaphragm/condom with spermicide. Unacceptable methods include oral or implanted contraceptives.
Exclusion criteria
Exclusion criteria: i. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. ii. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of bloodâ??forming organs. iii. History of Cardiovascular, Renal, Hepatic, Ophthalmic, Pulmonary, Neurological, Metabolic hematological, gastrointestinal, endocrine, immunological or Psychiatric Diseases. iv. Participation in any other clinical drug study or Bio-Equivalence study 90 days prior to present study. v. History of Malignancy or any other serious diseases. vi. Refusal to abstain from hot fluid and hot meal for one (1) hour prior to study drug administration on first day of each study period and for one (1) additional hour, post dosing, in each study period. vii. Refusal to abstain from food for ten (10) hours prior to study drug administration on day 1 and four (4) additional hours post dose, for all the study periods. viii. Any contraindication to blood sampling. ix. Refusal to abstain from smoking or consumption of tobacco products 72 hrs before dosing until after the last blood sample collection in each study period. x. Use of Xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks)or grapefruit juice and any alcoholic products, for 48 hrs prior to dosing until after the last blood sample collection in each study period. xi. Blood donation within 90 days prior to the commencement of the study. xii. Subjects with positive HIV tests, Australia Antigen or Hepatitis-C tests. xiii. Positive urine screen for drugs of abuse and breath alcohol test done during preenrolment process. xiv. Subject with nasal polyp, running nose, nasal congestion, allergic rhinitis or respiratory tract infection. xv. Known hypersensitivity to Mecobalamin. xvi. Use of Vitamin B12 for 72 hours before dosing of each period. xvii.Female subjects whose menstruation cycle coincides with the study dates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters: Cmax, AUC0-t, AUC0-inf Secondary parameters: t½, Kel, TmaxTimepoint: -10.00, -06.00, Pre-dose (pre-dose samples for baseline), 0.16,0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00 and 120.00 hours (post-dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: t½, Kel, TmaxTimepoint: -10.00, -06.00, Pre-dose (pre-dose samples for baseline), 0.16,0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00 and 120.00 hours (post-dose) | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Limited
Outcome results
None listed