Bioequivalence study of octreotide solid dose injection system
Research type
Research Study
Full title
A Clinical Study to Assess the Bioavailability, Tolerability, Pharmacokinetics and Safety of a Solid Dose Injection of Octreotide Compared With a Reference Product.
IRAS ID
195605
Contact name
Jon Telfer
Contact email
Sponsor organisation
Glide Pharmaceutical Technologies Limited
Eudract number
2015-005135-41
ISRCTN Number
ISRCTN72107545
Duration of Study in the UK
0 years, 0 months, 20 days
Research summary
This is a study to evaluate a single treatment dose delivered by a needle-free injection system being developed by the sponsor, in comparison to an already marketed version of the drug delivered by injection under the skin. \n\nThe study aims to determine if this solid dose injection system (SDI) used to deliver the treatment gives comparable pharmacokinetics to the marketed product delivered by the subcutaneous injection.\n\nTwenty healthy male subjects will be enrolled at BioKinetic. After giving consent they will undergo screening procedures 28 days before checking into the study unit. At screening the subjects will be given a demonstration of the test device by actuating a non-firing dummy device they will demonstrate that they are able to use it themselves. Those who clearly demonstrate that they can use it and pass screening requirements will be invited to return for treatment period 1.\n\nEach subject will stay in the study unit on the day before treatment period 1 (day -1) until the end of treatment period 2 on day 3 (3 nights).\n\nTreatment period one = a single dose of the treatment using the test SDI device \nTreatment period two = a single dose of the marketed treatment by subcutaneous injection.\n \nAll subjects will complete both treatments in a crossover fashion to enable comparison with a 12 hour washout in between periods.\n\nSeveral assessments will be carried out for safety, tolerability, comparability and drug concentration levels in the bloodstream. Subjects will be asked a number of questions regarding both methods of administration of the drug after both periods.\n\n12 hours after receiving the second dose in period 2 subjects can leave the unit. They will return for a post study assessment 2 - 7 days later.\n
REC name
HSC REC A
REC reference
16/NI/0032
Date of REC Opinion
29 Feb 2016
REC opinion
Favourable Opinion