None listed
Conditions
Interventions
Intervention1: 600 IU capsules of Vitamin D3 (Cholecalciferol) Plant Source.: In this study period, after overnight fasting of at least 10.00 hours, a single oral dose of four capsules of 600 IU eac
Sponsors
Fermenta Biotech Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Healthy human Participants aged between 18 and 45 years (including both). Participants with a BMI between 18.50-29.99 Kg per m2 (including both) but body weight not less than 50 Kgs. Participants with normal health as determined by personal medical history, Clinical examination and laboratory examinations including serological tests during the screening as per section 5.3. Participants having normal 12-lead electrocardiogram (ECG). Participants having normal chest X-Ray (Posterior-Anterior view) whose X-Ray was taken not more than 180 days prior to the check-in of Period-I. Participants who are able to communicate effectively. Participants willing to give written informed consent and adhere to all the requirements of this protocol. Participants who agree to abstain from consuming any xanthine and or caffeine containing products, tobacco (nicotine) containing products, grapefruit juice and products and alcohol during the course of the study. Participant is a non-smoker or moderate smoker (not more than 09 cigarettes or beedis per day). Participant is a non-alcoholic or without any history of alcoholic abuse (Alcohol abuse will be defined as more than 14 drinks per week (1 drink is equal to 360 mL beer, 150 mL wine or 45 mL hard liquor). Additional inclusion criteria for female Participants, 1) Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence: or 2) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the participant).
Exclusion criteria
Exclusion criteria: Participants having contraindications or hypersensitivity to study drug or related group of drugs. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission e.g., fasting due to religious reasons. History or presence of Hypertension. ,History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission. Positive results for alcohol consumption during the admission. Intolerance to venipuncture. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. History or presence of any medical condition or disease according to the opinion of the physician. Difficulty with donating blood. Major illness during 90 days before period-I check-in. Participation in a drug research study within past 90 days of period-I check-in. Donation of blood (i.e. one unit or 350 mL) in the past 90 days before period-I check-in. Difficulty in swallowing solid dosage forms like capsules. Additional exclusion criteria for female Participants, 1) Participant demonstrating a positive pregnancy test. 2) Participants who are pregnant, currently breast-feeding or who are likely to become pregnant during the study. 3) Participants who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relative Bioavailability (Cmax, AUC0-t and AUC0-inf) of Vitamin D3 (Cholecalciferol) Plant Source (Test) compared to Vitamin D3 (Conventional) (reference) in healthy adult human Participants under fasting conditions.Timepoint: Pre-dose blood samples will be drawn at minus 24.00, minus 16.00, minus 8.00 and 0.00 hours. The post dose samples at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 15.00, 16.00, 24.00, 28.00, 48.00 and 72.00 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Tmax, Kel, t1/2 of Vitamin D3 (Cholecalciferol) Plant Source (Test) compared to Vitamin D3 (Conventional) (reference) in healthy adult human Participants under fasting conditions. To monitor the safety and tolerability of a single dose of an Investigational Product in healthy human adult Participants under fasting conditions.Timepoint: Pre-dose blood samples will be drawn at minus 24.00, minus 16.00, minus 8.00 and 0.00 hours. The post dose samples at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 15.00, 16.00, 24.00, 28.00, 48.00 and 72.00 hours. | — |
Countries
India
Contacts
Public ContactHarshad K More
Vedic Lifesciences Pvt Ltd
Outcome results
None listed