Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
As noted above in "Brief Summary".
Age
12–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1\) Only subjects who are eligible for and have entered into Protocol TDE-PH-304 may participate in this substudy.
You may not be if
1. The subject must voluntarily give informed consent to participate in the substudy.
2. No dose changes to study drug are made within 5 days of the pharmacokinetic (PK)substudy visits.
3. No additions or deletions to concurrent medications are made within 7 days of the pharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants are permitted.
4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior to the BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure a trough level of study drug for PK sampling.
5. Subject dosing of study drug on the day of PK sampling must be observed in the clinic by study personnel.
6. Subject has not experienced a significant loss of blood (\> 450 mL) within the last 6 weeks of the pharmacokinetic substudy visit.
7. The subject must not be receiving any CYP 2C8 inducers or inhibitors
Clareo Health | A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
