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Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets | Clinical Trials | Clareo Health

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Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg and 'Trintellix' (Vortioxetine) Tablets 20 mg in Healthy Adult Human Subjects Under Fasting Conditions

NCT05417087•Seasons Biotechnology (Taizhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

An open label, randomized, three-period, three-treatment \[Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)\], six-sequence, crossover, balanced, single dose oral bioequivalence study.

Detailed Description

Single dose oral bioequivalence study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg and 'Trintellix' (Vortioxetine) Tablets 20 mg in healthy adult human subjects under fasting conditions. * To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg (administered without water and with water) with that of 'Trintellix' (Vortioxetine) Tablets 20 mg in healthy, adult, human subjects under fasting conditions. * To monitor the safety and tolerability of the subjects. An open label, randomized, three-period, three-treatment \[Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)\], six-sequence, crossover, balanced, single dose oral bioequivalence study.

Eligibility

Age

25 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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 (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.
•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:
+4 more criteria

Exclusion Criteria

•Volunteers must not be enrolled in the study if they meet any one of the following 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 http://medicine.iupui.edu/clinpharm/ddis/main-table).
•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.
+19 more criteria

Locations (1)

Cliantha Research Limited

Ahmedabad, Gujarat, India

Key Dates

Start Date

June 27, 2022

Primary Completion Date

September 2, 2022

Completion Date

September 2, 2022

Last Updated

April 13, 2023

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder (MDD)

Interventions

Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

DRUG

Vortioxetine Hydrobromide Tablets

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Inclusion Criteria

Exclusion Criteria

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