A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

Adocia

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BioChaperone Lispro U-200

Drug: BioChaperone Lispro U-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT02529293

BC3-CT012

Details and patient eligibility

About

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

Enrollment

26 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
Age ≥ 18 and ≤ 64 years, both inclusive.
Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion criteria

Known or suspected hypersensitivity to trial product(s) or related products.
Receipt of any investigational medicinal product within 3 months before randomisation in this trial.