Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
Status:
Completed
Trial end date:
2023-12-18
Target enrollment:
Participant gender:
Summary
The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg
Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product,
Lumacaftor 200 mg /Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) in the fed
state, and food-effect bioavailability of Lumacaftor 200 mg Film-Coated Tablet Formulation
(Qanatpharma) in the fasted and fed state in healthy, non-smoking, male and non-pregnant
female volunteers, 18 to 55 years of age, inclusive.