None listed
Conditions
Interventions
Intervention1: Tafamidis Tablets 61 mg: Dose: 61 mg
Frequency: Single dose, single period
Route of administration: Oral
Duration of study: 05 days
Manufactured by: Dr. Reddy s Laboratories Limited, In
Sponsors
Dr. Reddy s Laboratories Limited, India
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers must fulfil all of the following criteria to be considered for inclusion into this study: 1. Healthy, adult, humans aged between 18 to 45 years (both inclusive). 2. Body mass index between 18.50 kg/m2 and 30.00 kg/m2 (both inclusive) and weight 45 kgs or above. 3. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the check-in in the study period. 4. Non-smoker and non-alcoholics. 5. Having normal 12-lead electrocardiogram (ECG). 6. Having normal chest X- Ray (P/A view). 7. Able to communicate effectively. 8. Willing to give written informed consent and adhere to protocol requirements as evidenced by written informed consent approved by an Ethics Committee (EC). 9. Male trial participant who is practicing an acceptable method of birth control using condoms or vasectomy or spermicide or effective contraception for the study duration as judged by the investigator(s) 10. Female trial participant who is of child bearing potential practicing an acceptable method of birth control using non-hormonal contraceptives such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study judged by the investigator(s)Or Is postmenopausal for at least 1 year Or Is surgically sterile
Exclusion criteria
Exclusion criteria: Volunteers will not be eligible for study participation if any of the following criteria is met: 1.History of contraindications or hypersensitivity to Tafamidis or any of the excipients in the formulation. 2. Tested positive for VDRL, HIV (1 & 2) Antibodies, HbsAg (Hepatitis B Surface Antigen) and HCV Antibodies during serologic tests. 3. Presence of urinary retention, gastric retention and uncontrolled narrow-angle glaucoma. 4. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, hematological, ophthalmic dermatological, infectious, neurological or psychiatric disease. 5. Who are on strong CYP3A4 inhibitors (e.g., ketoconazole, voriconazole and clarithromycin), strong CYP3A4 inducers (e.g., rifampin, St. John s Wort, and phenytoin) and BCRP substrates (e.g., methotrexate, rosuvastatin, imatinib). 6. History of cholestatic jaundice/hepatic dysfunction and pancreatitis. 7. History of exacerbation of symptoms of myasthenia gravis. 8. History or presence of significant drug abuse in the past one year. 9. Difficulty with donating blood or difficulty in accessibility of veins. 10. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. 11. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. 12. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 13. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 14. Usage of any prescribed medication or OTC medicinal products or herbal medications during last 14 days preceding the first dosing. 15. Major illness during 90 days before screening. 16. Usage of any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study. 17. Tested positive for urine or Breath alcohol test and urine screen for drugs of abuse such as cocaine, cannabinoids (marijuana/tetra hydro cannabinoids-THC), amphetamine, barbiturates, benzodiazepines and opioids at the time of check-in. 18. Female trial participant who is pregnant or lactating or Having Amenorrhea during past 6 months Or Having unprotected sex with any nonsterile male partner drug and unwilling to follow for the duration of the study Or Tested positive for serum beta hCG test at the time of check-in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of test product (T) Tafamidis Tablets 61 mg of Dr. Reddy s Laboratories Limited, India comparing with reference product (R) Tafamidis tablets 61 mg of Pfizer labs, Division of Pfizer INC. NY, USA in normal, healthy, adult, human trial participants under fed condition.Timepoint: Pre-dose to 72.000 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Tafamidis Tablets 61 mg in normal, healthy, adult, human trial participants under fed condition.Timepoint: Pre-dose to 72.000 hours post dose | — |
Countries
India
Contacts
Public ContactMr S Sri Harsha
ZenRise Clinical Research Private Limited
Outcome results
None listed