Status:
COMPLETED
Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects
Lead Sponsor:
Biocon Limited
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Healthy Volunteers
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's Human Insulin R U-500 with Humulin® R U-500 in healthy subjects. The treatment consists of one...
Eligibility Criteria
Inclusion
- Healthy male or post-menopausal female subjects. The post-menopausal state is defined as no menses for 12 months 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 (BMI) between 18.5 and 29.0 kg/m2, both inclusive.
- Fasting plasma glucose concentration ≤ 100 mg/dL.
- Considered generally healthy upon completing the medical history and screening safety assessments, as judged by the Investigator.
Exclusion
- Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
- Systolic blood pressure \< 90 mmHg or \> 139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg after resting for at least 5 minutes in the 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05413863
Start Date
May 30 2022
End Date
December 12 2022
Last Update
May 9 2023
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH 9
Neuss, Germany, D-41460