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
Information source: Adocia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: BioChaperone Lispro U-100 (Drug); BioChaperone Lispro U-200 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Adocia Official(s) and/or principal investigator(s): Grit Andersen, MD, Principal Investigator, Affiliation: Profil Institut Für Stoffwechselfforschung GmbH
Overall contact: Grit Andersen, MD, Phone: +49 2131 4018-0
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.
Clinical Details
Official title: A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: AUCLisp (0-inf)Cmax Lisp
Secondary outcome: tmax LispAUCGIR(0-8h) GIRmax tGIRmax Number of Adverse events Local tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
Locations and Contacts
Grit Andersen, MD, Phone: +49 2131 4018-0
Profil Institut für Stoffwechselforschung GmbH, Neuss 41460, Germany; Recruiting Grit Andersen, MD, Phone: +49 2131 4018-0
Additional Information
Starting date: August 2015
Last updated: August 20, 2015
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