NCT02459418 - Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application | Biotech Hunter

Enrollment

42

Participants

Timeline

Start Date

May 7, 2015

Primary Completion Date

May 19, 2016

Study Completion Date

May 19, 2016

Conditions

Healthy Volunteers

Interventions

DRUG

Afolia

"During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:~Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.~Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27"

DRUG

US Gonal-f®

"During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:~Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.~Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27"

Trial Locations (1)

SE1 1YR

Quintiles Drug Research Unit at Guy's Hospital, London