Major Depressive Disorder (MDD)Phase 1NCT05417087
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
A Phase 1 study testing Vortioxetine Hemihydrobromide Orally Disintegrating Tablets and Vortioxetine Hydrobromide Tablets in people with Major Depressive Disorder (MDD), run by Seasons Biotechnology (Taizhou) Co., Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets and Vortioxetine Hydrobromide Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 27 Jun 2022to 2 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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).
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- History of acute narrow-angle glaucoma.
- Serum sodium value is less than lower limit of normal reference ranges.
- History of bleeding problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets, Vortioxetine Hydrobromide Tablets
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine Hemihydrobromide Orally Disintegrating TabletsDrug
Also called SF001 ODT
Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg equivalent to 20 mg of Vortioxetine
Vortioxetine Hydrobromide TabletsDrug
Also called Trintellix
Vortioxetine Hydrobromide Tablets 20mg
| Study group | Role | What they receive |
|---|---|---|
| SF001 administered without water | Experimental | test product administered without water Receives: Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets |
| SF001 administered with water | Experimental | test product administered with water Receives: Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets |
| Trintellix | Experimental | Reference product administered with water Receives: Drug: Vortioxetine Hydrobromide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start27 Jun 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayur Soni, Ph.D., Principal investigator, Cliantha Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417087
- Sponsor's protocol ID
- C1B01561
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05417087
- Acronym / sponsor ID
- C1B01561
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SF001 administered without water | Experimental | Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tabletstest product administered without water |
| SF001 administered with water | Experimental | Drug: Vortioxetine Hemihydrobromide Orally Disintegrating Tabletstest product administered with water |
| Trintellix | Experimental | Drug: Vortioxetine Hydrobromide TabletsReference product administered with water |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine Hemihydrobromide Orally Disintegrating TabletsAlso: SF001 ODTVortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg equivalent to 20 mg of Vortioxetine | Drug | SF001 administered with water, SF001 administered without water |
| Vortioxetine Hydrobromide TabletsAlso: TrintellixVortioxetine Hydrobromide Tablets 20mg | Drug | Trintellix |
Primary outcome
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%
Time frame: 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. 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
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%
Time frame: 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. 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayur Soni, Ph.D. principal investigator
Cliantha Research Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vortioxetine Hemihydrobromide Orally Disintegrating Tablets and Vortioxetine Hydrobromide Tablets in people with Major Depressive Disorder (MDD), run by Seasons Biotechnology (Taizhou) Co., Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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% (time frame: In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.