None listed
Conditions
Interventions
Intervention1: Rifapentine 150 mg Tablets (Cipla Ltd., India): Single oral dose of one Rifapentine 150 mg Tablets.
Control Intervention1: PRIFTIN�® (rifapentine 150 mg) Tablets (Sanofi-Aventis U.S.
Sponsors
Cipla Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: Healthy willing adult human volunteers should have: an age between 18 to 45 years (both inclusive), having body mass index (BMI) between 18.5 and 30 kg/m2, weighing not less than 45 kg no medical history of significant diseases a physical examination, laboratory evaluations that are clinically not significant a negative or non-reactive Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV), antibodies to human immuno-deficiency Virus (HIV) I and II negative urine alcohol test negative urine test for drugs of abuse negative urine pregnancy test for females negative test for COVID-19 [Real Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) or Rapid antigen test] normal or clinically not significant chest X-ray vital signs examinations that are within clinically not significant limits no medical complaints
Exclusion criteria
Exclusion criteria: Volunteers will be excluded based on the following criteria: 1. Volunteers who have history of known hypersensitivity to rifamycin or related class of drug. 2. Volunteers having difficulty in swallowing tablet. 3. Volunteers with history of a known food allergy. 4. Volunteers who have vital signs abnormalities (systolic blood pressure less than 100 or greater than 140 mm of Hg or diastolic blood pressure less than 60 or greater than 90 mm of Hg or pulse rate less than 50 beats per minute or more than 100 beats per minute) during pre-study screening and vital signs examination before check-in. 5. Volunteers having any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract. 6. Volunteers who have history of severe cutaneous adverse reactions such as Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms syndrome. 7. Volunteers who have recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study check-in. 8. Volunteers who have clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, bleeding disorder, tumor/ cancer, eye, ear, nose and throat disease. 9. Volunteers who have suffered any clinically significant illness in the 2 weeks prior to dosing or who have been hospitalized within 3 months preceding the start of the study. 10. Volunteers who have taken any drug that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing. 11. Volunteers who have taken any prescription medication or over-the-counter products available (including vitamins and products from natural origin such as ayurvedic, unani, siddha and homeopathic medicines) and topical medication meant for systemic absorption, within the 7 days prior to dosing. 12. Volunteers who have depot injection or an implant of any drug within 3 months prior to dosing. 13. Volunteers who have a history of difficulty in donating blood. 14. Volunteers who have donated blood (1 unit or 350 mL) within 90 days prior to dosing. 15. Volunteers who have history of porphyria. 16. Volunteers who have taken any investigational product or participated in any drug research study requiring blood donation within 90 days prior to dosing. 17. Volunteers who have unsuitable veins for repeated venipuncture, evidence of skin lesions on forearm or signs of venipuncture on the forearm suggestive of recent blood donation or participation in a study. 18. Female volunteers who have clinically significant signs and symptoms or history of gynaecological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reference ââ?¬â?? Scale Average Bioequivalence Approach: When SWR ââ?°Â¥ 0.294 for any of the primary pharmacokinetic parameters of rifapentine, below mentioned both the criteria must be satisfied: Bioequivalence will be concluded if the 95% upper confidence bound will be less than or equal to 0 and the point estimate of the Test/Reference geometric mean ratio will fall within [0.80, 1.25] limit. Average Bioequivalence Approach: When SWR 0.294 for any of the primary pharmacokinetic parameters of rifapentine, 90% confidence interval for the geometric least square means ratio (T/R) of that parameter must fall within the acceptance range of 80.00% to 125.00%.Timepoint: A total of 21 blood samples will be collected per period, at pre-dose 0.00 hour and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours postdose | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax : Time until Cmax is reached. T1/2 : plasma concentration half-life. Residual area (%) : Extrapolated area [(AUC0-âË?ž - AUC0-t)/ AUC0-âË?ž] x 100. Kel : Terminal elimination rate constant. Timepoint: A total of 21 blood samples will be collected per period, at pre-dose 0.00 hour and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours postdose | — |
Countries
India
Contacts
Public ContactDr Hemant Joshi
Cipla Ltd
Outcome results
None listed