A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
Status:
Completed
Trial end date:
2018-01-29
Target enrollment:
Participant gender:
Summary
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult
subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382
after a single subcutaneous (SC) dose. The study will be conducted at a single US center.
Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose
of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a
washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans
previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose
and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose
levels will be monitored before meals and at bedtime during Days 1 and 10 and will be
measured prior to breakfast on Days 2 and 11.