None listed
Conditions
Interventions
Intervention1: Tafamidis Tablets 61 mg: Dose: 61 mg,
Frequency: Single dose, Two period,
Route of administration: Oral,
Duration of study: 26 days with washout period of 21 days
Control Intervention1:
Sponsors
Dr. Reddy s Laboratories Limited, India
Eligibility
Inclusion criteria
Inclusion criteria: Participants 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 more. 3. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the check-in of Period-I. 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 with female partner of reproductive potential who is willing to use effective contraception methods for the duration of the study as judged by the investigator(s). 10. Female trial participant of child bearing potential who is willing to follow an acceptable method of birth control for the duration of the study as judged by the investigator(s), Or Is postmenopausal for at least 1 year Or Is surgically sterile.
Exclusion criteria
Exclusion criteria: Participants 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. Difficulty in swallowing tablet/capsule. 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 and throughout the study. 15. Usage of any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study and throughout the study. 16. 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. 17. Female trial participant who is pregnant or lactating Or Having amenorrhea or irregular menstrual periods during past 6 months Or Having unprotected sex with any nonsterile male partner prior to drug administration 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), 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, healthy, adult, human trial participants under fasting conditionTimepoint: 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.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