None listed
Conditions
Interventions
Intervention1: Test Formulation I- Lactoferrin (30 mg)- sublingual: Dose : 30 mg
Dosage form :sublingual tablet
Route of administration: Orally
frequency and duration: From at least 12 hours prior to
Sponsors
Arna Immuno Ingredients Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteer aged between 20-50 years 2. Adhere to all study procedures 3. Provide written informed consent for participation in the trial 4. Agree to provide blood samples for study analysis
Exclusion criteria
Exclusion criteria: 1. History of allergy to known lacto based or herbal products 2. Patients with preexisting severe systemic disease necessitating long-term medication. 3. Evidence of significant uncontrolled co-morbid disease, like diabetes (Type I or II), which in the investigators opinion would jeopardize patient participation. 4. History of cancer, including solid tumours, hematologic malignancies and carcinoma. 5. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments. 6. Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the comparative bioavailability of Lactocetin in adult male healthy volunteers with that of Lactoferrin formulationsTimepoint: blood sampling: 00.05, 00.10. 00.15, 00.20, 00.30 00.40, 00.50, 01.00, 02.00, 04.00, 06.00, 08.00 and 12.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and oral tolerability of Lactocetin in adult male healthy volunteersTimepoint: Base line i,e Day 0 and end of the study Day 2 | — |
Countries
India
Contacts
Public ContactDrAnil Kumar
Radiant Research Services Pvt Ltd
Outcome results
None listed