Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Supernus Pharmaceuticals, Inc.
NAP
Age
18–66
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Able to provide written informed consent and agree to comply with study procedures.
2. Male or female aged 18 to 66 years, inclusive.
3. Successful completion of the 804P301 study.
4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication \[SM\] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to SM administration\] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.
You may not be if
1. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
