A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers - FT218 two batches bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44364

Enrollment

Registered

2017-08-07

Start date

2017-08-07

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Narcolepsy sleep / wake disorder

Interventions

The study will consist of 2 study periods during which the volunteer will receive a 4.5 grams dose of FT218 once in each study period. FT218 will be given as an oral drink (a suspension) of approxim

Bioequivalence

FT218

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Gender: healthy male or female Age: 18-65 years, inclusive, at screening BMI: 18.0-28.0 kg/m2, inclusive Weight: *60 kg

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first drug administration in the current study

Design outcomes

Primary

Measure	Time frame
To demonstrate the bioequivalence (BE) of the 2 different batches of FT218 at the dose of 4.5 g	—

Secondary

Measure	Time frame
To assess the safety and tolerability of the 2 different batches of FT218 taken 2 hours post-evening meal at the dose of 4.5 g in healthy volunteers	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)