Conditions: Hypogonadism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Detailed description:
This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

Arms:
arm 1: A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.

Interventions: intervention 1: Oral Testosterone Undecanoate
Intervention descriptions: intervention 1: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Protocol document: