Healthy Volunteer Clinical Trial
Official title:
A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin N and Humulin® N
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence
of Biocon Insulin N with Humulin® N in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered
during each of the three study periods, separated by 5-7 days between each dosing. The
planned trial duration for each subject is about 17 to 43 days. Eligible subjects will
undergo three euglycaemic clamp examinations (each of 24 hours duration).
Depending on the sequence in which a particular subject is randomized, each subject will
either undergo two clamps with administration of test product plus one clamp with
administration of reference product, or, two clamps with administration of reference product
plus one clamp with administration of test product, in random order.
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