A single-center, randomized, open-label, two cohort, two-period crossover study to investigate the bioequivalence of alpelisib optimized final market image formulation (FMIopt) and the final market image (FMI) tablet formulation in healthy volunteers in the fasted and fed state

Completed

• Conditions: breast cancer; cancer; 10027656

• Registration Number: NL-OMON46796
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

- healthy male and/or female volunteers
- 18-55 years, inclusive
- BMI: 18.0-29.9 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 30 days before the start of this study or being a blood donor within 8 weeks from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK parameter: Cmax, AUClast, AUCinf, and Tmax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PK parameter: AUC0-96, CL/F, Vz/F, T1/2, and MRTlast</p><br>