Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects
Open-label, Two-treatment, Single Period, Parallel, Single-dose, Randomized, Fasting, Lab-blinded Bioequivalence Study of Fulvestrant 50 mg/mL Versus Faslodex®, 50 mg/mL, in Healthy, Post-menopausal Female Subjects
1 other identifier
interventional
266
1 country
3
Brief Summary
The purpose of this study is to demonstrate bioequivalence between the test drug product, fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50 mg/mL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2016
Typical duration for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2017
CompletedMarch 9, 2017
July 1, 2016
9 months
May 30, 2016
March 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum observed plasma concentration
0-238 days
Area under the plasma concentration versus time curve (AUC0-238d) of fulvestrant
0-238 days
Secondary Outcomes (8)
Area under the plasma concentration versus time curve (AUC0-28d) of fulvestrant
0-28 day
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUC0-t)
0-238 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞)
0-238 days
Time to Reach the Maximum Plasma Concentration (Tmax)
0-238 days
Elimination Half-life Period (t1/2)
0-238 days
- +3 more secondary outcomes
Study Arms (2)
Fulvestrant 50mg/mL (Fresenius Kabi)
EXPERIMENTAL5 mL intramuscular injection
Fulvestrant 50 mg/mL (Faslodex®)
ACTIVE COMPARATOR5 mL intramuscular injection
Interventions
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)
Eligibility Criteria
You may qualify if:
- Normal, healthy, non smoking post-menopausal female subjects between the ages of 40 and 65 years (inclusive) Note: Postmenopausal is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL. The amenorrhea should not be due to lactation
- Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
- Physical examination, 12-lead electrocardiogram (ECG) and vital signs without any clinically significant findings
- Negative for urine drugs of abuse screen, urine nicotine (cotinine) screen, and breath alcohol screen.
- Negative for hepatitis B-surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV)
- Clinical laboratory values within the acceptable range, unless deemed clinically not significant by the principal investigator or sub-investigator.
- Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements as evidenced by signing the Informed Consent Form (ICF).
You may not qualify if:
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, musculoskeletal, psychiatric, or cardiovascular disease or malignancies or any other condition which, in the opinion of the principal investigator or sub-investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- A history of allergic or adverse response(s) to fulvestrant, castor oil, benzyl alcohol, benzyl benzoate, polysorbate 80, α-tocopherol or any other comparable or similar products.
- Smoking or use of tobacco products within 6 months prior to the first dose of study drug or during the study
- Positive urine pregnancy test at screening or serum pregnancy test prior to administration of study drug.
- History of any bleeding disorders
- Consumption of alcohol exceeding 10 drinks/ week in the previous 1 year
- Intolerance to/fear of venipuncture, needles or blood draws
- Have consumed any products or undergone any procedures mentioned under "restriction table" in protocol
- Surgically-induced post menopausal females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
Study Sites (3)
Lambda Therapeutic Research Inc.
Toronto, Ontario, M1L4S4, Canada
BioPharma Services Inc.
Toronto, Ontario, M9L 3A2, Canada
Algorithme Pharma Inc.
Mount Royal, Quebec, H3P 3P1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 9, 2016
Study Start
June 1, 2016
Primary Completion
March 3, 2017
Study Completion
March 3, 2017
Last Updated
March 9, 2017
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share