A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms
Status:
Completed
Trial end date:
2017-07-17
Target enrollment:
Participant gender:
Summary
This is a single-dose, randomized, two-period cross-over study with 72 healthy male and
female volunteers. The investigational products will be given (after fasting overnight) at
separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn
pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4,
5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture
any adverse events that may occur. Bioequivalence will be assessed based on the single-dose
pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide