Status:
COMPLETED
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30
Lead Sponsor:
Biocon Limited
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.
Detailed Description
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 in healthy subjects The treatment consists of one single dose o...
Eligibility Criteria
Inclusion
- Healthy male or post-menopausal female subjects. 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/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.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomization in this trial.
- Any history or presence of clinically relevant comorbidity, as judged by the investigator.
- 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.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04022291
Start Date
June 15 2019
End Date
January 27 2020
Last Update
January 30 2020
Active Locations (2)
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1
Profil Mainz GmbH & Co. KG Malakoff-Passage,Rheinstraße 4C D-55116
Mainz, Germany
2
Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss
Neuss, Germany