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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 Lisp

AUCGIR(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

Page last updated: August 23, 2015

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