A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R
Sponsor study identifier
interventional
42
1 country
1
Study Start
June 18, 2019
Actual (reported)Primary Completion
September 15, 2019
Actual (reported)Study Completion
September 20, 2019
Actual (reported)Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2019
Actual (reported)June 29, 2019
Actual (reported)July 17, 2019
Actual (reported)September 15, 2019
Actual (reported)September 20, 2019
Actual (reported)PK endpoints:Area under the insulin concentration curve(AUCins).0-12h
Area under the insulin concentration curve from 0 to 12 hours.
0-12 hours
PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
Area under the glucose infusion rate curve
0-12 hours
PK endpoints: Maximum observed insulin concentration(Cins.max)
Maximum observed insulin concentration
0-12 hours
PD endpoints:maximum glucose infusion rate(GIRmax)
maximum glucose infusion rate
0-12 hours
PK endpoint- Area under the insulin concentration curve(AUCins).0-2h
0 to 2 hours
PK endpoint- Area under the insulin concentration curve(AUCins).0-6h
0 to 6 hours
PK endpoint- Area under the insulin concentration curve(AUCins).6-12h
6 to 12 hours
PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity
0 hours to 24 hours
PK endpoint- time to maximum concentration( tmax)
0-12 hours
Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions
First dose to followup period (Total duration: 14 days approximate)
Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG)
Screening to Follow-up period (Total duration: 35 days approximate)
0.3 IU/kg Dose per administration, subcutaneous Route of administration
0.3 IU/kg Dose per administration, subcutaneous Route of administration
Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.
Profil Mainz GmbH
Mainz, Germany
Dr. Leona P Mörschel
Profil Mainz GmbH
42 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2019
First Posted
July 17, 2019
Study Start
June 18, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 15, 2019
Actual (reported)Study Completion
September 20, 2019
Actual (reported)Last Updated
July 28, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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