| Eligibility |
Inclusion Criteria:
1. Age: 25 to 45 years old, both inclusive.
2. Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing
potential must have a negative serum beta human chorionic gonadotropin (ß-HCG)
pregnancy test performed within 28 days prior to first dosing day. They must be using
an acceptable form of contraception.
B. For female of childbearing potential, acceptable forms of contraception include the
following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start
of the study and remaining in place during the study period, or ii. Barrier methods
containing or used in conjunction with a spermicidal agent, or iii. Surgical
sterilization or iv. Practicing sexual abstinence throughout the course of the study.
C. Female will not be considered of childbearing potential if one of the following is
reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral
oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6
months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
3. BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one
significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45
rounds up to 18.5).
4. Able to communicate effectively with study personnel.
5. Willing to provide written informed consent to participate in the study.
6. All volunteers must be judged by the principal or sub-investigator or physician as
normal and healthy during a pre-study safety assessment performed within 28 days of
the first dose of study medication which will include:
1. A physical examination (clinical examination) with no clinically significant
finding.
2. Results within normal limits or clinically non-significant for the following
tests:
- Additional tests and/or examinations (apart from mentioned in protocol) may
be performed, if necessary, based on principal investigator discretion.
- All results will be assessed against the current laboratory normal ranges at
the time of testing and a copy of the normal ranges used will be included in
the study documentation.
Exclusion Criteria:
1. History of allergic responses to Vortioxetine or other related drugs, or any of its
formulation ingredients.
2. Have significant diseases or clinically significant abnormal findings during screening
[medical history, physical examination (clinical examination), laboratory evaluations,
ECG, chest X-ray recording, gynecological history and examination (including pelvic
examination and routine breast examination) (for female volunteers)].
3. Any disease or condition like diabetes, psychosis or others, which might compromise
the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory,
central nervous system or any other body system.
4. History or presence of bronchial asthma.
5. Use of any hormone replacement therapy within 3 months prior to the first dose of
study medication.
6. A depot injection or implant of any drug within 3 months prior to the first dose of
study medication.
7. Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of
study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those
who cannot refrain from smoking during the study period.
10. History of difficulty with donating blood or difficulty in accessibility of veins.
11. A positive hepatitis screen (includes subtypes B & C).
12. A positive test result for HIV antibody and / or syphilis (RPR).
13. Volunteers who have received a known investigational drug within seven elimination
half-life of the administered drug prior to the first dose of study medication.
14. Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or
101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at
screening for this study) prior to first dose of study medication, whichever is
greater.
15. History of difficulty in swallowing or of any gastrointestinal disease, which could
affect drug absorption.
16. Intolerance to venipuncture
17. Any food allergy, intolerance, restriction or special diet that, in the opinion of the
principal investigator or sub-investigator, could contraindicate the volunteer's
participation in this study.
18. Institutionalized volunteers.
19. Use of any prescribed medications (including Mono Amine Oxidase Inhibitors,
serotonergic antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin,
or other drugs that affect coagulation) within 14 days prior to the first dose of
study medication.
20. Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the
first dose of study medication.
21. Use of grapefruit and grapefruit containing products within 7 days prior to the first
dose of study medication.
22. Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and
caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products,
recreational drugs, alcohol or other alcohol containing products within 48 hours prior
to the first dose of study medication.
23. Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks
prior to the first dose of study medication.
24. History of (or have a family history of) bipolar disorder or suicidal thoughts or
actions or any other psychiatric problems.
25. History of seizures or convulsions.
26. Symptoms of acute narrow-angle glaucoma.
27. Volunteer having serum sodium value is less than lower limit of normal reference
ranges during screening.
28. History of bleeding problems.
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