HealthyPhase 1NCT02795039
Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects
A Phase 1 study testing Fulvestrant in people with Healthy, run by Fresenius Kabi at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2016to 3 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Algorithme Pharma Inc.
Mount Royal, Quebec, H3P 3P1
Lambda Therapeutic Research Inc.
Toronto, Ontario, M1L4S4
BioPharma Services Inc.
Toronto, Ontario, M9L 3A2
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)
FulvestrantDrug
Also called Faslodex
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant 50mg/mL (Fresenius Kabi) | Experimental | 5 mL intramuscular injection Receives: Drug: Fulvestrant |
| Fulvestrant 50 mg/mL (Faslodex®) | Active comparator | 5 mL intramuscular injection Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration
Measured: 0-238 days
Area under the plasma concentration versus time curve (AUC0-238d) of fulvestrant
Measured: 0-238 days
Secondary outcomes (8)
Area under the plasma concentration versus time curve (AUC0-28d) of fulvestrant
Measured: 0-28 day
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUC0-t)
Measured: 0-238 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞)
Measured: 0-238 days
Time to Reach the Maximum Plasma Concentration (Tmax)
Measured: 0-238 days
Elimination Half-life Period (t1/2)
Measured: 0-238 days
Terminal Slope (λz)
Measured: 0-238 days
Residual area in percentage (AUC_%Extrap_obs)
Measured: 0-238 days
Injection site pain assessment
Measured: 0-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795039
- Sponsor's protocol ID
- FULV-006-CP1
- Status last verified
- Jul 2016
- First submitted
- 30 May 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02795039
- Acronym / sponsor ID
- FULV-006-CP1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant 50mg/mL (Fresenius Kabi) | Experimental | Drug: Fulvestrant5 mL intramuscular injection |
| Fulvestrant 50 mg/mL (Faslodex®) | Active comparator | Drug: Fulvestrant5 mL intramuscular injection |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantSingle 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant) | Drug | Fulvestrant 50mg/mL (Fresenius Kabi) |
| FulvestrantAlso: FaslodexSingle 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant) | Drug | Fulvestrant 50 mg/mL (Faslodex®) |
Primary outcome
Maximum observed plasma concentration
Time frame: 0-238 days
Area under the plasma concentration versus time curve (AUC0-238d) of fulvestrant
Time frame: 0-238 days
8 secondary outcomes
Area under the plasma concentration versus time curve (AUC0-28d) of fulvestrant
Time frame: 0-28 day
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUC0-t)
Time frame: 0-238 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞)
Time frame: 0-238 days
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: 0-238 days
Elimination Half-life Period (t1/2)
Time frame: 0-238 days
Terminal Slope (λz)
Time frame: 0-238 days
Residual area in percentage (AUC_%Extrap_obs)
Time frame: 0-238 days
Injection site pain assessment
Time frame: 0-8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fulvestrant in people with Healthy, run by Fresenius Kabi at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (time frame: 0-238 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.