Pharmacokintetics, safety and tolerability study of subcutaneous Rizatriptan (DFN-10) in healthy subjects

Pharmacokintetics, safety and tolerability study of subcutaneous Rizatriptan (DFN-10) in healthy subjects - DFN-10 SAD and bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42170

Enrollment

Registered

2014-10-20

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

headache migraine

Interventions

Part A: The study will consist of 1 period during which you will receive a single dose of DFN-10 or a single dose of placebo. A placebo is the same formulation without the active ingredient. DFN-10

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects (female only for Part B) 18 - 45 yrs, inclusive 20.0 - 29.0 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 60 days before the start of this study or being a blood donor within 60 days 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
- To assess the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) injection of DFN-10 (0.5, 1.0, 2.0 and 3.0 mg) in healthy adult subjects under fasting conditions - To evaluate and compare the PK parameters of rizatriptan following sc injection of DFN-10 and oral administration of 10 mg Maxalt® (rizatriptan benzoate) tablets in healthy adult subjects under fasting conditions	—

Measure

Time frame

- To assess the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) injection of DFN-10 (0.5, 1.0, 2.0 and 3.0 mg) in healthy adult subjects under fasting conditions - To evaluate and compare the PK parameters of rizatriptan following sc injection of DFN-10 and oral administration of 10 mg Maxalt® (rizatriptan benzoate) tablets in healthy adult subjects under fasting conditions

—

Secondary

Measure	Time frame
To evaluate and compare the safety and tolerability of DFN-10 and Maxalt® in healthy adult male and female volunteers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)