Finding studies
Finding studies
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Lead
Lannett Company, Inc.
With
This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence crossover clamp study performed at a single study center. The study population consists of healthy adult male subjects. The study will comprise of: * A screening period: maximum 28 days prior to first dose administration. * Admission: Subjects will be admitted to the study center on Day -1 * Two Treatment Periods (Treatment Periods 1 and 2): Subjects will be randomized to either of the 2 treatment sequences (AB or BA) on Day 1 of Treatment Period 1 to receive either test or reference product as per randomization schedule in a 1:1 ratio. * Treatment A (Test Formulation): HEC-Glargine * Treatment B (Reference Formulation): US-Lantus® On Day 1 of each Treatment Period, the study drug or reference product will be administered as a single morning dose to subjects in a fasting state. There will be a wash-out period of at least 7 calendar days. Each subject will receive both test and reference products in a crossover pattern over Treatment Periods 1 and 2.
Age
18–55
Sex
MALE
Healthy volunteers
Accepted
