None listed
Conditions
Interventions
Intervention1: Vitamin E 400 mg capsules: Vitamin E 400 mg capsules (dl-alpha-Tocopheryl acetate) of Troikaa Pharmaceuticals Ltd India
Control Intervention1: Evion 400 mg capsules: Evion 400 mg (dl-al
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2 (both inclusive) Subjects who are able to understand and willing to comply with the protocol requirements Subjects who are able to understand willing to voluntarily provide written informed consent Subjects who are able to understand and willing to adhere to protocol and the following study requirements Should not consume xanthine containing products such as coffee tea chocolate or soft drinks at least 24 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection Subjects who are non-alcoholic, non-smokers and not consuming any tobacco products (based on history)
Exclusion criteria
Exclusion criteria: Subjects incapable of understanding and signing the informed consent document Pregnant and lactating women (currently breast-feeding) Presence of pregnancy will be confirmed by Serum (β) Beta- hCG (Human Chorionic Gonadotropin) test before check-in Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria at least 14 days prior to the first dose of study medication until the post-study follow-up. Use of hormonal contraceptives either oral or implants will not be acceptable Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study Subjects with abnormalities in resting heart rate ( >100 beats/min or = 140 mmHg or diastolic blood pressure >= 90 mmHg) on the screening day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of product in relation to the Rate of absorption, Extent of absorption Cmax AUC0-72Timepoint: -12.00 -6.00 hr -2 hr 0 hr 0.33 0.67 1.00 1.50 2.00 2.50 3.00 4.00 6.00 10.00 12.00 14.00 16.00 24.00 36.00 48.00 72.00 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Laboratory abnormalities Tmax t1/2 KelTimepoint: -12.00 -6.00 hr -2 hr 0 hr 0.33 0.67 1.00 1.50 2.00 2.50 3.00 4.00 6.00 10.00 12.00 14.00 16.00 24.00 36.00 48.00 72.00 | — |
Countries
India
Contacts
Public ContactDr Suresh Maroli
Reliance Life Sciences Pvt Ltd
Outcome results
None listed