Clinical trial
A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State.
NCT05968612 is registered in ClinicalTrials.gov with Qanatpharma Canada LTD as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State.
- Lead sponsor
- Qanatpharma Canada LTD
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- November 17, 2023
- Completion date
- December 18, 2023
- Enrollment
- 39 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy volunteer