Trial Profile
A Randomized, Open-Label, Single Dose, Cross-Over Study To Investigate The Bioequivalence Of Three RO5424802 Test Formulations Versus A Reference Formulation Following Oral Administration In Healthy Subjects
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 15 Dec 2023
Price :
$35
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At a glance
- Drugs Alectinib (Primary)
- Indications Non-small cell lung cancer
- Focus Pharmacokinetics
- Sponsors Roche
- 12 Mar 2016 Primary endpoint has not been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 12.5% and 3% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
- 12 Mar 2016 Primary endpoint has been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 25% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
- 12 Mar 2016 Results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics