Healthy volunteers Bioequivalence Linagliptin Tablet 5 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Linagliptin Tablets 5 mg with 250 mL of drinking water. ,The marketed original products which were alrea
Experimental Drug,Active Comparator Drug
Linagliptin Tablets 5 mg,Originator Linagliptin Tablets 5 mg
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 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 based on laboratory evaluations, medical history or prior surgeries during screening. Some laboratory values, e.g., complete blood count, that are outside the normal range will be carefully considered by physician.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Linagliptin, any related drugs or any excipients of this product. 2. Participants with B.P. is Systolic B.P < 90, >= 140 mm/Hg, Diastolic B.P < 60, >= 90 mm/Hg or 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. 7. Have more than one abnormal EKG, which is considered as clinically significant. * 8. History or evidence of heart, renal, hepatic disease, Chronic Obstructive Pulmonary Disease, bronchial asthma, diabetes mellitus. 9. History or evidence of rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 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 or present of psychiatric disorder. 13. 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. 14. History of regular smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) and cannot stop at least 7 days before the study drug administration and until the completion of each period of 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 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. 17. Positive drug abused test in urine (Marijuana (THC), Cocaine, Opioids, Methamphetamine and Benzodiazepines). 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 medication and until 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. Participate 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 Linagliptin level pre-dose (0.00 hour) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.33, 2.67, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00 and 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) at check-in, pre-dose, at approximately 1.0, 2.0, 4.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours post-dose Automatic blood pressure,Adverse event monitoring All participants will be monitored under the supervision of medical staff since investigational study drug dosing administration until approximately the day 28 after the last blood sample collection clinical laboratory monitoring, physician decision | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed