Status:
COMPLETED
A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
Lead Sponsor:
Adocia
Collaborating Sponsors:
Tonghua Dongbao Pharmaceutical Co.,Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers. Each subject will be randomly allocated to one of 6 t...
Detailed Description
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilis...
Eligibility Criteria
Inclusion
- Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
- BMI between 18.5 and 30.0 kg/m2, both inclusive.
- Fasting plasma glucose concentration \<= 5.6 mmol/L (100 mg/dL).
Exclusion
- Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
- Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
- Women of childbearing potential who are not using a highly effective contraceptive method.
- Any history or presence of a life-threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
- Heart rate at rest outside the range of 50-90 beats per minute.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05373186
Start Date
May 12 2022
End Date
December 4 2022
Last Update
October 12 2023
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460