TCTR20260710024Active, not recruitingPhase 1
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vortioxetine 20 mg Tablets relative to Brintellix (Vortioxetine tablets 20mg), in healthy Thai participants under fasting condition
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bio-innova Co., Ltd.
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •Healthy Thai participants are between 18 to 55 years of age.
- •The Body Mass Index (BMI) ranges from 18.5 to 30.0 kg/m
- •Comprehensive understanding of the nature and purpose of the study, compliance with the requirements of the entire protocol and consent to blood collection by investigators of approximately 10 mL for screening process, approximately 7 mL of blood for re-screening and approximately 7 mL for monitoring participants safety after completion of the study.
- •Negative urine pregnancy test for women and no breast-feeding.
- •Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. complete blood count etc. that out of the normal range will be carefully considered by physician.
Exclusion Criteria
- •History or evidence of allergy or hypersensitivity Vortioxetine or any related drugs or any of the excipients of this product.
- •Participant with a systolic blood pressure (BP) < 90 or >= 140 mmHg, diastolic BP < 60 or >= 90 mmHg, and pulse rate > 100 beats per minute.
- •Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- •Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- •Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- •Positive of hepatitis B and C virus.
- •Have more than one abnormal EKG, which is considered clinically significant. *
- •History or evidence of cardiac, renal, hepatic disease, chronic obstructive pulmonary disease, bronchial asthma, hypertension or glaucoma.
- •History of seizures or with conditions that lower the seizure threshold, e.g., Alzheimers dementia, severe head trauma.
- •History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
- •History or presence of major active bleeding or abnormal bleeding due to hemorrhoids, epistaxis, gastrointestinal ulcer or other symptoms in past 1 month before the study drug administration and until the completion of the study.
- •Any major illness in the past 3 months or any significant ongoing chronic medical illness.
- •History or evidence of psychiatric disorders including depression, bipolar disorder, suicidal thoughts, behaviors, or suicide attempts.
- •Hyponatremia*
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •History of regular smoking (more than 10 cigarettes per day within past 1 year), or moderate smoking (less than 10 cigarettes per day) if cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
- •History of St. Johns Wort products consumption and cannot stop at least 28 days before the study drug administration and until the completion of each period of the study.
- •Positive drug abuse test in urine (Marijuana (THC), Cocaine, Opioids Methamphetamine, and Benzodiazepines).
- •Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the study medication and until completion of each period the study.
- •History of difficulty in accessibility of veins in left and right arm.
- •Blood donation (one unit or 450 mL) within the past 3 months before the study.
- •Participation in any clinical study within the past 3 months before the study.
- •Participants who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- •*Depending on
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