Status:
COMPLETED
Single Dose Study to Evaluate Dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Lead Sponsor:
Seasons Biotechnology (Taizhou) Co., Ltd.
Conditions:
Major Depressive Disorder (MDD
Eligibility:
All Genders
25-45 years
Phase:
PHASE1
Brief Summary
An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced, single dose, dose proportionality study.
Detailed Description
Single dose study to evaluate dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets (5 mg, 10 mg and 20 mg) in healthy adult human subjects under fasting conditions. * T...
Eligibility Criteria
Inclusion
- Age: 25 to 45 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-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.
- 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).
- Able to communicate effectively with study personnel.
- Willing to provide written informed consent to participate in the study.
- 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:
- A physical examination (clinical examination) with no clinically significant finding.
- 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
- History of allergic responses to Vortioxetine or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
- 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.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- 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).
- History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- 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.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody and / or syphilis (RPR).
- 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.
- 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.
- History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- Intolerance to venipuncture
- 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.
- Institutionalized volunteers.
- 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.
- Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- 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.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- History of (or have a family history of) bipolar disorder or suicidal thoughts or actions or any other psychiatric problems.
- History of seizures or convulsions.
- Symptoms of acute narrow-angle glaucoma.
- Volunteer having serum sodium value is less than lower limit of normal reference ranges during screening.
- History of bleeding problems.
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05416762
Start Date
September 19 2022
End Date
November 25 2022
Last Update
April 13 2023
Active Locations (1)
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1
Cliantha Research Limited
Ahmedabad, Gujarat, India, 382210