Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

NCT05417087 | Completed Phase 1

• 1 other identifier: C1B01561
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

• Plasma samples will be tested. PK parameter Cmax will be reported. Ratios of PK parameters on SF001 ODT and Trintellix fall within 80.00% to 125.00%

  PK parameters will be determined using a non-compartmental analysis. T/R ratio will be reported for Cmax. Ln-transformed Cmax should be within 80.00% to 125.00% with 90% confidence intervals as bioequivelence

  In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose

• Plasma samples will be tested. PK parameter AUCi will be reported. Ratios of PK parameters on SF001 ODT and Trintellix fall within 80.00% to 125.00%

  PK parameters will be determined using a non-compartmental analysis. T/R ratio will be reported for AUCi. Ln-transformed AUCi should be within 80.00% to 125.00% with 90% confidence intervals as bioequivelence

  In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose

Study Arms (3)

SF001 administered without water

EXPERIMENTAL

test product administered without water

Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

SF001 administered with water

EXPERIMENTAL

test product administered with water

Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Trintellix

EXPERIMENTAL

Reference product administered with water

Drug: Vortioxetine Hydrobromide Tablets

Interventions

Vortioxetine Hemihydrobromide Orally Disintegrating Tablets DRUG

Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg equivalent to 20 mg of Vortioxetine

Also known as: SF001 ODT

SF001 administered with water; SF001 administered without water

Vortioxetine Hydrobromide Tablets DRUG

Vortioxetine Hydrobromide Tablets 20mg

Also known as: Trintellix

Trintellix

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seasons Biotechnology (Taizhou) Co., Ltd.: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 382210, India

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mayur Soni, Ph.D.

  Cliantha Research Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 14, 2022
• Study Start: June 27, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)