Relative bioavailability of fingolimod (2Ã?0.25 mg) vs. FMI, 0.5 mg capsule in healthy volunteers

An open-label, single dose, crossover study to evaluate the relative bioavailability of a new fingolimod formulation (2Ã?0.25 mg) in comparison to the Final Market Image (FMI, 0.5 mg) in healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002326

Enrollment

Registered

2012-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Fingolimod (FTY720) new capsule formulation 0.25 mg (Test): Single dose as 2x0.25 mg Control Intervention1: (1Ã?0.5 mg) Fingolimod (FTY720) FMI capsule (Reference): Single Dose

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy subjects 2. Female subjects must be of non-child bearing potential 3. Subjects must weigh at least 50 kg and their BMI should be within range of 18-30 kg/m2

Exclusion criteria

Exclusion criteria: 1. Smokers 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. Pregnant or nursing (lactating) women 4. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result 5. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
To determine the relative bioavailability of new fingolimod formulation (2 Ã? 0.25 mg) against the Final Market Image (FMI, 0.5 mg)Timepoint: Two single dose treatment periods, seperated by a washout of 36 days between dosing and end-of study evaluation at the last PK sample time point	—

Secondary

Measure	Time frame
To assess safety and tolerability of a single fingolimod dose in healthy volunteers.Timepoint: Monitoring of AE throughout the study	—

Countries

India

Contacts

Public ContactPrafulla Bhad

Novartis Healthcare Pvt. Ltd.,

prafulla.bhad@novartis.com914067673283

Outcome results