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Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795039
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fulvestrant Phase 1

Detailed Description:

This study is being conducted to establish bioequivalence between sponsor's test product [fulvestrant Injection, 50 mg/mL (Manufactured for Fresenius Kabi, USA)] and reference listed drug [Faslodex® Injection, 50 mg/mL, (Distributed by AstraZeneca Pharmaceuticals, USA] after intramuscular administration of a 250 mg dose (5 mL injection) into the upper outer quadrant of the right buttock to normal, healthy, nonsmoking post-menopausal female subjects.

The order of receiving the test product (T) or reference listed drug (R) for each subject during the study will be determined according to a randomization schedule.

Subjects will be allocated with a ratio of 1:1 to both treatment groups (i.e. T and R).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : June 2016
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Fulvestrant 50mg/mL (Fresenius Kabi)
5 mL intramuscular injection
Drug: Fulvestrant
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)

Active Comparator: Fulvestrant 50 mg/mL (Faslodex®)
5 mL intramuscular injection
Drug: Fulvestrant
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)
Other Name: Faslodex




Primary Outcome Measures :
  1. Maximum observed plasma concentration [ Time Frame: 0-238 days ]
  2. Area under the plasma concentration versus time curve (AUC0-238d) of fulvestrant [ Time Frame: 0-238 days ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC0-28d) of fulvestrant [ Time Frame: 0-28 day ]
  2. Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUC0-t) [ Time Frame: 0-238 days ]
  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞) [ Time Frame: 0-238 days ]
  4. Time to Reach the Maximum Plasma Concentration (Tmax) [ Time Frame: 0-238 days ]
  5. Elimination Half-life Period (t1/2) [ Time Frame: 0-238 days ]
  6. Terminal Slope (λz) [ Time Frame: 0-238 days ]
  7. Residual area in percentage (AUC_%Extrap_obs) [ Time Frame: 0-238 days ]
  8. Injection site pain assessment [ Time Frame: 0-8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795039


Locations
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Canada, Ontario
Lambda Therapeutic Research Inc.
Toronto, Ontario, Canada, M1L4S4
BioPharma Services Inc.
Toronto, Ontario, Canada, M9L 3A2
Canada, Quebec
Algorithme Pharma Inc.
Mount Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Fresenius Kabi
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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT02795039    
Other Study ID Numbers: FULV-006-CP1
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs