Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Study Details
Study Description
Brief Summary
An open label, randomized, two-period, two-treatment [Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Single dose oral food effect bioavailability study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy adult human subjects under fasting and fed conditions.
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To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy, adult, human subjects under fasting and fed conditions.
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To monitor the safety and tolerability of the subjects. An open label, randomized, two-period, two-treatment [Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SF001 ODT administered under fasting condition Investigational product administration under fasting condition |
Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg administration under fasting condition
Other Names:
|
| Experimental: SF001 ODT administration under fed condition Investigational product administration under fed condition |
Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg administration under fasting condition
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Plasma samples will be tested. PK parameters Cmax on FED and FAST conditions will be reported. Ratios of PK parameters on FED and FAST fall within 80.00% to 125.00% [In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose]
PK parameters will be determined using a non-compartmental analysis. Absence of food effect will be concluded if the 90% confidence intervals of the Treatment B (Investigational product administration under fed condition) / Treatment A (Investigational product administration under fasting condition) ratios of relative mean (Geometric mean) of Vortioxetine fall within 80.00% to 125.00% for Ln-transformed Cmax
- Plasma samples will be tested. PK parameters AUCi on FED and FAST conditions will be reported. Ratios of PK parameters on FED and FAST fall within 80.00% to 125.00% [In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose]
PK parameters will be determined using a non-compartmental analysis. Absence of food effect will be concluded if the 90% confidence intervals of the Treatment B (Investigational product administration under fed condition) / Treatment A (Investigational product administration under fasting condition) ratios of relative mean (Geometric mean) of Vortioxetine fall within 80.00% to 125.00% for Ln-transformed AUCi
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 25 to 45 years old, both inclusive.
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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.
- For female of childbearing potential, acceptable forms of contraception include the following:
- 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.
- Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- 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.
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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).
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Able to communicate effectively with study personnel.
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Willing to provide written informed consent to participate in the study.
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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:
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A physical examination (clinical examination) with no clinically significant finding.
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Results within normal limits or clinically non-significant for the following tests:
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Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
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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:
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History of allergic responses to Vortioxetine or other related drugs, or any of its formulation ingredients.
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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)].
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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.
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History or presence of bronchial asthma.
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Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
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A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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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).
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History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
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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.
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History of difficulty with donating blood or difficulty in accessibility of veins.
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A positive hepatitis screen (includes subtypes B & C).
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A positive test result for HIV antibody and / or syphilis (RPR).
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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.
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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.
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History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
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Intolerance to venipuncture
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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.
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Institutionalized volunteers.
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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.
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Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
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Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
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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.
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Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
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History of (or have a family history of) bipolar disorder or suicidal thoughts or actions or any other psychiatric problems.
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History of seizures or convulsions.
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Symptoms of acute narrow-angle glaucoma.
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Volunteer having serum sodium value is less than lower limit of normal reference ranges during screening.
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History of bleeding problems.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliantha Research Limited | Ahmedabad | Gujarat | India | 382210 |
Sponsors and Collaborators
- Seasons Biotechnology (Taizhou) Co., Ltd.
Investigators
- Principal Investigator: Minesh Patel, Ph.D., Cliantha Research Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C1B02240