Healthy volunteers Bioequivalence Levothyroxine Sodium formulations (LevT-100- mcg-Tablet)
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Levothyroxine Sodium formulations (LevT-100- mcg-Tablet) with total 250 mL of drinking water. ,The marke
Experimental Drug,Active Comparator Drug
Levothyroxine Sodium formulations (LevT-100- mcg-Tablet),Originator Euthyrox (Merck) Levothyroxine Tablets
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy adult human Thai participants are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30.0 kg/m2. 4. Comprehensive understanding of the nature and purpose of the study, compliance with the requirements of the entire protocol and agreement to allow investigators to collect approximately 10 mL of blood for screening approximately 7 mL of blood for re-screening and approximately 7 mL of blood for monitoring participants safety after completion of the study. 5. Negative urine pregnancy test for women and no breast-feeding. 6. 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
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Levothyroxine Sodium, any related drugs or any excipients of this product. 2. Participant with B.P. is Systolic B.P < 90, >= 140 mm/Hg, Diastolic B.P < 60, >= 90 mm/Hg, pulse rate > 100 beats per minute. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive of hepatitis B, C virus or HIV. 7. Thyroid function test outside limits of reference range* 8. Have more than one abnormal EKG, which is considered as clinically significant. * 9. History or evidence of heart, renal, hepatic disease, Chronic Obstructive Pulmonary Disease, bronchial asthma, hypertension, hypotension, hyperthyroidism, hypothyroidism, diabetes mellitus, adrenal cortical insufficiency, pituitary insufficiency, or malignant tumors. 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 12. History of psychiatric disorder. 13. History or ongoing alcoholism within 4 weeks prior to first dosing of study treatment. and until the completion of the study. Note: Alcohol consumption is prohibited 1 week prior to dosing and until the completion of the study. 14. Smoker or use of tobacco products or products containing nicotine within 4 weeks prior to first dosing of study treatment and until the completion of the study. Note: Smokers will be defined as any participant who reports the use of a product containing nicotine during the preceding 30 days or has a positive urine cotinine test > 200 ng/mL, if test is performed, and will not participate in the study. 15. 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. 16. History of grapefruit, pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 17. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 18. 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 first dose of study and until the completion of each period of the study. 19. History of difficulty in accessibility of veins in left and right arm. 20. Blood donation (one unit or 450 mL) within the past 3 months before the study. 21. Participation in any clinical study within the past 3 months before the study. 22. Participants who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. (* Depend on decision of principal investigator and/or clinical investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Levothyroxine Sodium level predose at -0.50, -0.25 and 0.00 hour and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 4.75, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) check-in, pre-dose, at approximately 1.0, 3.0, 4.0, 8.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours post-dose Automatic blood pressure,Adverse event monitoring Reported by the participants or observed by the investigator clinical laboratory monitoring, physician decision | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed