Status:
COMPLETED
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
Lead Sponsor:
Biocon Limited
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (\>= 25.8 IU/L).
- Age between 18 and 55 years, both inclusive
- Body mass index between 18.5 and 29.0 kg/m\^2, both inclusive.
- Fasting plasma glucose concentration \<= 100 mg/dl.
- Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
Exclusion
- Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
- 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).
- Pulse rate at rest outside the range of 50-90 beats per minute.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04022304
Start Date
June 15 2019
End Date
December 27 2019
Last Update
January 30 2020
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany