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The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.
Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [Baseline], Weeks 4, 8, 12, 16, 20, and 24).
The study was expected to enroll over approximately 6 to 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FX006 16 mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release formulation |
|
| FX006 32 mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release formulation |
|
| Placebo | Placebo Comparator | Normal Saline Single 5 mL intra-articular (IA) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX006 32 mg | Drug | Single 5 mL IA injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine." | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 for WOMAC C (Function Subscale) | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria | Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function. | Weeks 4, 8 and 12 |
| Change From Baseline to Week 12 for WOMAC C (Function Subscale) |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Bodick, MD | Flexion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29088579 | Derived | Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20. |
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Subjects were screened within 21 days of being randomized
Patients were screened for study eligibility at 48 study centers in the United States (US) and Canada. Enrollment took approximately 7 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | FX006 16 mg | 102 subjects received FX006 16 mg a single 5 mL IA injection |
| FG001 | FX006 32 mg | 104 subjects received FX006 32 mg a single 5 mL IA injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Single 5 mL IA injection |
|
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| FX006 16 mg | Drug | Single 5 mL IA injection |
|
| Baseline and Week 12 |
| Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Baseline and Week 12 |
| Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Baseline and Weeks 16, 20 and 24 |
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Baseline and Week 12 |
| Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Baseline and Week 12 |
| Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group | Baseline and Up to Week 24 |
| Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure) |
| Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Baseline and Weeks 4, 8, 12, 16, 20 and 24 |
| Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure) |
| Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12 | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | 12 weeks |
| Time to Onset of Pain Relief | Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline. | Baseline up to 24 Weeks after administration of study treatment |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Mobile | Alabama | 36608 | United States |
| Phoenix | Arizona | 85023 | United States |
| Tucson | Arizona | 85704 | United States |
| Hot Springs | Arkansas | 71913 | United States |
| Anaheim | California | 92801 | United States |
| Canoga Park | California | 91303 | United States |
| El Cajon | California | 92020 | United States |
| Los Angeles | California | 90036 | United States |
| North Hollywood | California | 91606 | United States |
| San Diego | California | 92103 | United States |
| Stamford | Connecticut | 06905 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Orlando | Florida | 32825 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Tampa | Florida | 33613 | United States |
| Marietta | Georgia | 30060 | United States |
| Evansville | Indiana | 47713 | United States |
| Paducah | Kentucky | 42003 | United States |
| Wheaton | Maryland | 20902 | United States |
| New Bedford | Massachusetts | 02740 | United States |
| Troy | Michigan | 48085 | United States |
| Kansas City | Missouri | 64114 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| New York | New York | 10018 | United States |
| Rochester | New York | 14609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77055 | United States |
| San Antonio | Texas | 78258 | United States |
| Victoria | Texas | 77901 | United States |
| Danville | Virginia | 24541 | United States |
| Kitchener | Ontario | Canada |
| Sarnia | Ontario | Canada |
| Toronto | Ontario | Canada |
| Windsor | Ontario | Canada |
| Québec | Canada |
| FG002 | Placebo | 100 subjects received normal saline as a single 5 mL IA injection |
| COMPLETED |
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| NOT COMPLETED |
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A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | FX006 16 mg | Single intra-articular injection FX006: Single intra-articular injection |
| BG001 | FX006 32 mg | Single intra-articular injection FX006: Single intra-articular injection |
| BG002 | Normal Saline | Single intra-articular injection Normal saline: Single intra-articular injection |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine." | Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 12 for WOMAC C (Function Subscale) | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Randomized patients who received study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Weeks 16, 20 and 24 |
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| Other Pre-specified | Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria | Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function. | Percent of responders according to Outcomes Measures in OMERACT-OARSI strict criteria for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported. | Posted | Count of Participants | Participants | Weeks 4, 8 and 12 |
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| Other Pre-specified | Change From Baseline to Week 12 for WOMAC C (Function Subscale) | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Other Pre-specified | Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Other Pre-specified | Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group | Randomized patients who received study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Up to Week 24 |
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| Other Pre-specified | Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure) |
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| Other Pre-specified | Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Change from baseline to each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A pain for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Weeks 4, 8, 12, 16, 20 and 24 |
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| Other Pre-specified | Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC | The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. | Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in PGIC for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure) |
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| Other Pre-specified | Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12 | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Not Posted | 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Onset of Pain Relief | Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline. | Time to onset of pain relief for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported. | Posted | Median | 95% Confidence Interval | days | Baseline up to 24 Weeks after administration of study treatment |
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Adverse Events were collected following IA administration through the final study visit.
A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FX006 16 mg | Single 5 mL IA injection | 0 | 102 | 1 | 102 | 14 | 102 |
| EG001 | FX006 32 mg | Single 5 mL IA injection | 0 | 104 | 3 | 104 | 13 | 104 |
| EG002 | Placebo | Single 5 mL IA injection | 0 | 100 | 0 | 100 | 21 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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Subsequent to completion of clinical studies extensive testing was performed to assess the actual dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg and from FX006 20 mg vial is 16 mg.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Kelley, VP of Medical Affairs | Flexion Therapeutics | 781-305-7142 | skelley@flexiontherapeutics.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000631825 | FX006 |
| D014221 | Triamcinolone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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