CompletedPhase 1ACTRN12614000330640

Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices

IPX234-B13-01: Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices in healthy volunteers

Sponsor

Impax Laboratories, Inc

Enrollment

14 participants

Start Date

May 20, 2014

Study Type

Interventional

Conditions

Migraine

Summary

To compare the pharmacokinetics and safety of dihydroergotamine delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator. Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days. Investigational product, dosage and mode of administration: IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria1

Healthy male and female subjects between 18 years and 40 years of age inclusive at the time of Screening

Exclusion Criteria2

Presence of a clinically significant disorder including acute or chronic infections, or a malignant neoplasm, and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators
An upper respiratory tract infection or any other acute illness, including active allergic rhinitis, at Screening or at Check-in for each treatment period that the investigator believes may interfere with the administration, nasal retention, or absorption of study drug; or any prior medical conditions that, in the opinion of the Investigator, would interfere or modify the nasal administration, retention, or absorption of study drug

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Interventions

Objective: To compare the pharmacokinetics and safety of dihydroergotamine (DHE) delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator. Methods

Objective: To compare the pharmacokinetics and safety of dihydroergotamine (DHE) delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator. Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days. Investigational product, dosage and mode of administration: IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device which is being developed to optimize the delivery of drugs to the upper nasal cavity in order to improve the distribution profile of central nervous system (CNS) targeting drugs. Reference product, dosage and mode of administration: Migranal (dihydroergotamine mesylate, USP) Nasal Spray. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the Migranal nasal spray applicator. Traditional nasal pumps, such as the Migranal Nasal Spray applicator, typically only deliver a small fraction of drug to upper nasal cavity.