MedPath

A comparative Bioavailability study of multi vitamin formulations in Healthy Human Volunteers.

Phase 3
Registration Number
CTRI/2024/06/068755
Lead Sponsor
Vidya Herbs Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Subjects with Body mass index (BMI) of 18-25 kg/m2.

2. Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.

3. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.

Exclusion Criteria

1.Subjects who have consumed food rich in Vitamin A, D and B5, 2 days prior to screening.

2.History of consumption medications known to interact with Multivitamin.

3.Subjects having symptoms of viral infection.

4.Pregnant or lactating women.

5.History of

•Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis, Kidney disease, kidney stones, cardiac conditions, Recent blood donation (within 1 month) ,Current smoker or has quit smoking within last 3 months,Alcoholism and/or drug abuse, or heavy drinkers ,Immunodeficiency disease,Allergy, medication or supplement use that influences the immune system

6.Subjects with known hypersensitivity to the investigational products.

7.Subjects who have participated in any clinical trial in the past 1 month.

8.Any subjects found to have entered into the study in violation of this protocol or if the subject is uncooperative during the study.

9.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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