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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adocia
• Treatments: Insulin Lispro

Criteria

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.