Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
NCT ID: NCT04022304
Last Updated: 2020-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2019-06-15
2019-12-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Sequence: Humulin® N- Biocon Insulin N-Humulin® N
Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Sequence: Biocon Insulin N- Humulin® N- Humulin® N
Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Sequence: Humulin® N- Humulin® N-Biocon Insulin N
Period 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N
Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N
Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N
Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days
Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Interventions
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Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 55 years, both inclusive
3. Body mass index between 18.5 and 29.0 kg/m\^2, both inclusive.
4. Fasting plasma glucose concentration \<= 100 mg/dl.
5. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
Exclusion Criteria
2. Systolic blood pressure \< 95 mmHg or \>140 mmHg and/or diastolic blood pressure \< 50 mm Hg or \>90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
3. Pulse rate at rest outside the range of 50-90 beats per minute.
4. Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
18 Years
55 Years
ALL
Yes
Sponsors
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Profil Institut für Stoffwechselforschung GmbH
INDUSTRY
Biocon Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Grit Andersen
Role: PRINCIPAL_INVESTIGATOR
Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]
Locations
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Profil Institut für Stoffwechselforschung GmbH
Neuss, , Germany
Countries
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Other Identifiers
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EQN
Identifier Type: -
Identifier Source: org_study_id
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