Multiple Dose, Crossover Food Effect Study of Oral Testosterone
Research type
Research Study
Full title
Randomised, Multiple-Dose, Crossover Food Effect Study of Oral Testosterone Undecanoate Capsule Product in Hypogonadal Men
IRAS ID
193337
Contact name
Adrian/J Stewart
Contact email
Sponsor organisation
Solural Pharma ApS
Eudract number
2015-004489-27
Duration of Study in the UK
0 years, 5 months, 12 days
Research summary
The primary purpose of this study is to define the dose levels and capsule strengths of Testosterone Undecanoate to be used in the Clinical Phase 3 studies based on the FDA guidance for Cmax and Cavg testosterone levels at steady state under both fed (with food) and fasting conditions (without food). The Clinical Trial will be conducted at one centre in the UK and one in the USA , and will involve 32 hypogonadal male participants.
REC name
HSC REC A
REC reference
15/NI/0237
Date of REC Opinion
27 Nov 2015
REC opinion
Unfavourable Opinion