CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Afolia +1 moredrug
Likely dose
Afolia 225IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02459418
NCT02459418Phase 1Completed
CompareCT.gov

Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application. A Randomised, Open Label, 2-way Cross-over Study

Fertility Biotech AG·interventional·Posted Jun 2, 2015·Updated Jun 29, 2018

In Brief

A Phase 1 clinical trial evaluating Afolia and US Gonal-f® for Healthy Volunteers. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartMay 7, 2015
Primary CompletionMay 19, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 11.1 years ago

Interventions

Afoliadrug

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

US Gonal-f®drug

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