Healthy volunteers Bioequivalence Tramadol Hydrochloride and Paracetamol Tablets 37.5 mg/325 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of MYOTRAM-P 37.5/325 mg (Tramadol Hydrochloride and Paracetamol Tablets 37.5 mg/325 mg) with 250 mL of dri
Experimental Drug,Active Comparator Drug
MYOTRAM-P 37.5/325 mg (Tramadol Hydrochloride and Paracetamol Tablets 37.5 mg/325 mg),Ultracet (37.5 mg Tramadol HCl/ 325 mg Paracetamol 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 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 and approximately 7 mL of blood for monitoring participants safety after the 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 Tramadol Hydrochloride or Paracetamol or any of the excipients of this product. 2. Participants with B.P. is Systolic B.P < 100, >= 140 mm/Hg, Diastolic B.P < 70, >= 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 or HIV. 7. Have more than one abnormal EKG, which is considered as clinically significant. * 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, hypotension or glaucoma. 9. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 10. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 11. History of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer s dementia, severe head trauma. 12. History of psychiatric disorder, suicidal thoughts, behavior or suicide attempt 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 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/xanthine 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 the study 17. History of St. John s Wort products consumption and cannot stop at least 28 days before the study drug administration and until the completion of the study. 18. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 19. 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. 20. History of difficulty in accessibility of veins in left and right arm. 21. Blood donation (one unit or 450 mL) within the past 3 months before the study. 22. Participate in any clinical study within the past 3 months before the study. 23. 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 Tramadol Hydrochloride and Paracetamol level 0.00 and 0.083, 0.167, 0.333, 0.500, 0.667, 0.750, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000 and 36.000 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, 2.0, 4.0, 12.0, 24.0 and 36.0 hours post-dose Automatic blood pressure,EKG at 3.0-6.0 hours post-dose 12-lead EKG,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