Pharmacokintetics, safety and tolerability study of subcutaneous Rizatriptan (DFN-10) in healthy subjects
Completed
- Conditions
- headachemigraine10019231
- Registration Number
- NL-OMON42170
- Lead Sponsor
- Dr. Reddy's Laboratories Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To assess the pharmacokinetics (PK), safety and tolerability of a single<br /><br>subcutaneous (sc) injection of DFN-10 (0.5, 1.0, 2.0 and 3.0 mg) in healthy<br /><br>adult subjects under fasting conditions<br /><br><br /><br>- To evaluate and compare the PK parameters of rizatriptan following sc<br /><br>injection of DFN-10 and oral administration of 10 mg Maxalt® (rizatriptan<br /><br>benzoate) tablets in healthy adult subjects under fasting conditions</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate and compare the safety and tolerability of DFN-10 and Maxalt® in<br /><br>healthy adult male and female volunteers</p><br>