Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets (NCT05968612) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
Canada39 participantsStarted 2023-11-17
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy, non-smoking male and non-pregnant female volunteers, 18 years to 55 years of age, inclusive.
✓. Body mass index (BMI) that is between 18.5 and 30.0 kg/m\^2, inclusive.
✓. Results of clinical laboratory tests are within the normal range or with a deviation that is not considered clinically significant by the principal investigator.
✓. Ability to fast for at least 10 hours and consume a high-fat, high-calorie meal, as well as standard meals.
✓. Agree not to have a tattoo or body piercing until the end of the study.
✓. Agree not to receive the COVID-19 vaccination from 7 days prior to the first study drug dose until 7 days after the last study drug administration in the study.
✓. Female subjects of childbearing potential and males who are able to father children must meet the criteria defined in the protocol.
Exclusion criteria
✕. Known history or presence of any clinically significant diseases or conditions unless determined as not clinically significant by the Investigator.
✕. Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Investigator.
✕. Presence of any significant physical or organ abnormality as determined by the Investigator.
✕. A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol breath test and cotinine. Positive pregnancy test for female subjects.
What they're measuring
1
The maximal observed plasma concentration (Cmax)
Timeframe: Up to 72 hours post dose in each treatment period
2
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Timeframe: Up to 72 hours post dose in each treatment period
3
Area under the concentration-time curve from time zero to infinity (AUCinf)
Timeframe: Up to 72 hours post dose in each treatment period
4
Time when the maximal plasma concentration is observed (Tmax)
Timeframe: Up to 72 hours post dose in each treatment period