A Bioequivalence Study of the Lu AA21004 20 mg and 2x10 mg Tablets
- Conditions
- Healthy adult participants
- Registration Number
- JPRN-jRCT2080223807
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Evaluation of bioequivalence between single dosing of one Vortioxetine 20 mg tablet under fasted conditions and single dosing of two Vortioxetine 10 mg tablets under fasted conditions in healthy adults showed that the two formulations were biologically equivalent. Single dosing of one Vortioxetine 20 mg tablet or two Vortioxetine 10 mg tablets in healthy adults under fasted conditions was well tolerated with no safety concerns.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 28
1. Be a healthy Japanese adult volunteer.
2. Understand the contents of the study and is capable of providing written consent to participate in the study.
3. Be willing to comply with all study procedures and restrictions.
4. Aged between >=20 and =<45 years at the time of screening.
5. Have a BMI of >=18.5 and =<24.9 (kg/m^2) and a body weight of >=50 kg at the time of screening.
6. Be a extensive metabolizer (EM) based on CYP2D6 genotyping at the time of screening.
7. A female participant of childbearing potential with a non-sterilized male partner must agree to routinely use appropriate contraception during the study from the time of signing informed consent until 4 weeks after last dosing of the study drug.
1. Has received any investigational drug within 90 days before screening for this study.
2. Previously received Lu AA21004 before participation in this study.
3. Is an employee of the sponsor or the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may be coerced to provide consent.
4. Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may affect study participation or study results.
5. Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription drugs, over the counter (OTC) drugs, or foods.
6. Has a positive pregnancy test at the time of screening or Day -1.
7. Is a pregnant or lactating female.
8. Has a positive urine drug screen test at the time of screening or Day -1.
9. Has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
10. Consumes 6 or more servings of caffeinated beverages (containing about 120 mg of caffeine per serving) such as of coffee, tea, cola, or energy drinks.
11. Is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the Period 1 study drug administration.
12. Used any of the excluded drugs, dietary products or foods during the specified time periods, or will need any of them during the study period.
13. Has any current or recent gastrointestinal diseases that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn), or any surgical intervention (Stomach, cholecystectomy etc.).
14. Has a history of cancer.
15. Has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.
16. Has poor peripheral venous access.
17. Has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of Period 1 study drug administration.
18. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of Period 1 study drug administration.
19. Has undergone blood component collection within 2 weeks (14 days) prior to the start of Period 1 study drug administration.
20. Has any clinically relevant abnormality in vital signs or 12-lead electrocardiograms (ECG) at screening or on Day -1 of Period 1.
21. Has abnormal laboratory test values at screening or on Day -1 of Period 1 indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 x upper limit of normal (ULN).
22. Is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>AUClast: Area under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004<br>Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose<br>pharmacokinetics<br>Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004<br>Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
- Secondary Outcome Measures
Name Time Method