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

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 - BE Alpelisib FMIopt vs FMI tablet

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46796

Enrollment

Registered

2018-02-21

Start date

2018-05-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer cancer

Interventions

Alpelisib will be given as single oral tablet (200 milligram) with 250 mL of (tap) water. The volunteer will need to swallow the tablet without chewing. One of the investigators will inspect the han

we call this randomization. The participants will also be randomized in 2 groups: - Group 1 receives the study compound after you have eaten a high-fat breakfast - Group 2 receives the study compou

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
PK parameter: Cmax, AUClast, AUCinf, and Tmax	—

Secondary

Measure	Time frame
PK parameter: AUC0-96, CL/F, Vz/F, T1/2, and MRTlast	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)