BioequivalencePhase 1No acronymsNCT07769359
Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects
A Phase 1 study testing Rotigotine Transdermal Delivery System (TDS) in people with Bioequivalence and Adhesion, run by Amarin Technologies S.A.U. at 1 site in India.
Trial summary
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes. Local and systemic adverse events were also monitored and reported. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Adhesion, Adverse Effects
- What is being tested?
- Rotigotine Transdermal Delivery System (TDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- 4 Dec 2025to 26 Feb 2026
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first patch application. They must be using an acceptable form of contraception.
- For female of childbearing potential, acceptable forms of contraception include the following:
- Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
- Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level > 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.
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- BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- Non-alcoholic (i.e. having no past history of alcohol consumption for at least one year prior to study).
- Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- Able to communicate effectively with study personnel.
- Willing to provide written informed consent to participate in the study.
- All participants must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first patch application of study which will include:
- A physical examination (clinical examination) with no clinically significant finding.
- Results within normal limits or clinically non-significant for the following tests:
- Hematology Hemoglobin Total RBC count Total WBC count Platelet count
- Differential leukocyte count:
- Neutrophils Lymphocytes Eosinophils Monocytes Basophils Blood indices: HCT Biochemistry BUN Serum creatinine Random glucose SGPT \& SGOT Alkaline phosphatase Uric acid Serum bilirubin Serum total protein: Total proteins, Albumin Serum electrolytes: Serum sodium, serum chloride, serum potassium, serum phosphorous, serum calcium Urinalysis Color, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment) Immunological Tests HIV-I \& II HbsAg Anti HCV Serum (β-HCG) pregnancy test (for female of child-bearing potential) Serum Follicular Stimulating Hormone (FSH) (if required)
- Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigators recommendation.
- All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Who cannot join
- Participants must not be enrolled in the study if they meet any one of the following criteria:
- History of allergic responses to Rotigotine, or any other components of the formulations (Test and/or Reference ones) or other related drugs and/or history of allergy to any adhesive materials.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, gynaecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
- Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to the first patch application.
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- A depot injection or implant of any drug within 3 months prior to the first patch application.
- Use of CYP enzyme inhibitors or inducers within 30 days prior to the first patch application (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- History or evidence of narcotic abuse, drug dependence.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody.
- Participants who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first patch application.
- Participants who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first patch application, whichever is greater.
- Intolerance to venipuncture
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant's participation in this study.
- Institutionalized participants.
- Participant has an obvious difference in skin color at the application site or the presence of a skin condition, excessive hair at the application sites, scar tissue, tattoos, open sores, a recent sunburn, or body piercing that would interfere with the placement of the investigational products, the skin assessment, or the participant's reactions to the study patch.
- Presence of open sores, or other skin abnormalities at the application site.
- Use of creams, make up, lotions, powders and gels, etc. or other topical products at application sites within 24 hours prior to first patch application.
- Use of soap and/or solvents (e.g.: alcohol) at the patch application site within 12 hours prior to first patch application.
- Medical history of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).
- Medical history of condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as human immunodeficiency virus (HIV) positive or AIDS, allergic disease such as anaphylaxis, asthma or generalized drug reaction, neoplasms such as lymphoma or leukemia, rheumatoid arthritis or systemic lupus erythematosus).
- Medical history of significant dermatological cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.
- Use of any antihistamines (except steroid nose drops and/or eye drops) or used any topical drugs at application site within 72 hours prior to first patch application.
- Use of medications or treatments that would significantly influence or exaggerate responses to the investigational product or that would alter inflammatory or immune response to the product [e.g. cyclosporine, tacrolimus, cytotoxic drugs, immunoglobulins, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy] within 3 weeks prior to first patch application.
- Use of any systemic or topical corticosteroids at the application site within 3 weeks prior to first patch application.
- Participant who has a condition or is taking or has taken a medication that, in the investigator's judgment, makes the participant ineligible or places the participant at undue risk.
- Participation in any transdermal/topical patch with active drug study or any patch study at the same application site within the last four weeks prior to the initial application of study patch.
- Use of any prescribed medications within 14 days prior to the first patch application.
- Use of any over-the-counter medications, including topical or systemic analgesics, herbal medications, vitamins, etc. 07 days prior to the first patch application.
- Use of grapefruit and grapefruit containing products within 7 days prior to the first patch application.
- Use of sunbath or steam baths within 7 days prior to first patch application
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) within 72 hours prior to the first patch application.
- Ingestion of any recreational drugs within 14 days prior to the first patch application.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first patch application.
- History of sulfite sensitivity
- Medical history of asthma, orthostatic hypotension, dizziness, syncope, or dyskinesia
- History of hyper or hypotension
- Use of any monoamine oxidase (MAO) inhibitors, catechol-O-methyltransferase inhibitors, dopamine agonists, dopamine antagonists, reserpine, methyldopa, antipsychotics, neuroleptics, clozapine, olanzapine, quetiapine, metoclopramide, flunarizine, cinnarizine, risperidone within 3 months prior to first patch application. Use of any other medication that could alter the analysis of Rotigotine in plasma.
- Medical history of somnolence and/or having fallen asleep without warning.
- Medical history or presence of psychotic disorder.
- History of suicide attempt or suicide-leading thinking within 6 months prior to patch application.
- Clinically relevant findings in screening 12-lead ECG, such as second-or third-degree atrioventricular block or complete bundle branch block or arrhythmias.
- The participant shows a QTc interval (corrected according Bazett formula) ≥ 430 ms for men and ≥ 450 ms for women.
- History of narrow angle glaucoma.
- Participant that recently or currently have (had) pain, irritation and/or other sensory disturbances at or adjacent to the area of application that could hamper assessment of the safety and tolerability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Bioequivalence and Adhesion Study of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 Hours) and 'NEUPRO®' (Rotigotine) 2 mg/24 Hours Transdermal Patch in Healthy Adult Human Participants.
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes. Local and systemic adverse events were also monitored and reported. Worn patches were recovered and analysed to compare residual drug.
Read the detailed description
Objectives:
- To evaluate the bioequivalence and the non-inferiority in the adhesion of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) respect to 'NEUPRO®' (Rotigotine) 2 mg/24 hours Transdermal Patch in healthy, adult human participants.
- To compare the residual drug content, cold flow properties and to monitor the safety and tolerability of the participants.
Methodology:
This evaluator-blinded, randomized, two-period, two-treatment, four-sequence, crossover, balanced, single dose bioequivalence and adhesion study in healthy adult human participants was conducted to evaluate the bioequivalence and the non-inferiority in the adhesion of test formulation respect to reference formulation. The study was conducted with 36 (32 Male + 04 Female) participants and 35 participants (31 Male + 04 Female) completed the study in accordance with protocol. A single patch of either the test product Rotigotina B7 TDS (2mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) (T) or the reference product (R). Neupro® 2 mg/24 h Transdermal Patch Rotigotin (e) was applied for 24 hours on the healthy skin (that was clean, dry, hairless and free of redness, irritation, burns or cuts) on left or right side of upper arm according to the randomization schedule of each participant in each study period (on Day 0 for Period 1 and Day 3 for Period 2) at ambient temperature.
Blood samples were collected at pre-dose (0.0 hour) and at 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0, 14.0, 15.0, 16.0, 17.0, 18.0, 19.0, 20.0, 22.0, 24.0 (prior to removal), 26.0, 28.0, 32.0, 36.0, 42.0 and 48.0 hours post dose in each period. The plasma samples were shipped to the Bioanalytical facility for analysis.
Statistical analysis was performed on pharmacokinetic parameters to compare and evaluate the bioequivalence and statistical analysis was performed on adhesion score data to evaluate the non-inferiority in the adhesion of test formulation to the reference formulation. Bioequivalence was determined by a statistical comparison of Cmax, AUCt and AUCi for the test and reference products for Rotigotine. To demonstrate adhesiveness, the 90% confidence interval of mean adherence for the test product at the end of the dosing interval was to be lie above 90%.
- Conditions
- Bioequivalence, Adhesion, Adverse Effects
- Being tested
- Rotigotine Transdermal Delivery System (TDS)
- Keywords
- Rotigotine patch adhesion and bioequivalence
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine Transdermal Delivery System (TDS)Combination product
Strength: 2 mg/24 hours
| Study group | Role | What they receive |
|---|---|---|
| Test / Reference | Other | Rotigotina B7 TDS (Test) / Neupro® (Reference) Receives: Combination Product: Rotigotine Transdermal Delivery System (TDS) |
| Reference / Test | Other | Neupro® (Reference) / Rotigotina B7 TDS (Test) Receives: Combination Product: Rotigotine Transdermal Delivery System (TDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax
Peak Plasma Concentration (Cmax) 90% confidence limits of T/R ratio must lie within 80-125 %
Measured: 24 Hours
Non-Inferiority in Adhesion
The Test patch adhesion 90% LCL must lie above 90%.
Measured: 24 Hours
Bioequivalence based on AUC 0-t
The area under the plasma concentration versus time curve (AUC 0-t) 90% confidence limits of T/R ratio must lie within 80-125 %
Measured: 24 Hours
Bioequivalence based on AUCi
The area under the plasma concentration versus time curve extrapolated to infinite (AUC i) 90% confidence limits of T/R ratio must lie within 80-125 %
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start4 Dec 2025
- Primary completion17 Dec 2025
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Crossover
- Model description
- evaluator-blinded, randomized, two-period, two-treatment, crossover, balanced, single dose.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amarin Technologies S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769359
- Sponsor's protocol ID
- C1B05695
- Acronym
- No acronyms
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Legal and/or Ethical as well as Confidential complexities might apply.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Bioequivalence and Adhesion Study of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 Hours) and 'NEUPRO®' (Rotigotine) 2 mg/24 Hours Transdermal Patch in Healthy Adult Human Participants.
- ClinicalTrials.gov ID
- NCT07769359
- Acronym / sponsor ID
- No acronyms / C1B05695
- Conditions
- Bioequivalence, Adhesion, Adverse Effects
- Keywords
- Rotigotine patch adhesion and bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Amarin Technologies S.A.U.Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research Ltd.
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 17 Aug 2026 (actual)
- 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.
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes. Local and systemic adverse events were also monitored and reported. Worn patches were recovered and analysed to compare residual drug.
Detailed description
Objectives:
- To evaluate the bioequivalence and the non-inferiority in the adhesion of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) respect to 'NEUPRO®' (Rotigotine) 2 mg/24 hours Transdermal Patch in healthy, adult human participants.
- To compare the residual drug content, cold flow properties and to monitor the safety and tolerability of the participants.
Methodology:
This evaluator-blinded, randomized, two-period, two-treatment, four-sequence, crossover, balanced, single dose bioequivalence and adhesion study in healthy adult human participants was conducted to evaluate the bioequivalence and the non-inferiority in the adhesion of test formulation respect to reference formulation. The study was conducted with 36 (32 Male + 04 Female) participants and 35 participants (31 Male + 04 Female) completed the study in accordance with protocol. A single patch of either the test product Rotigotina B7 TDS (2mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) (T) or the reference product (R). Neupro® 2 mg/24 h Transdermal Patch Rotigotin (e) was applied for 24 hours on the healthy skin (that was clean, dry, hairless and free of redness, irritation, burns or cuts) on left or right side of upper arm according to the randomization schedule of each participant in each study period (on Day 0 for Period 1 and Day 3 for Period 2) at ambient temperature.
Blood samples were collected at pre-dose (0.0 hour) and at 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0, 14.0, 15.0, 16.0, 17.0, 18.0, 19.0, 20.0, 22.0, 24.0 (prior to removal), 26.0, 28.0, 32.0, 36.0, 42.0 and 48.0 hours post dose in each period. The plasma samples were shipped to the Bioanalytical facility for analysis.
Statistical analysis was performed on pharmacokinetic parameters to compare and evaluate the bioequivalence and statistical analysis was performed on adhesion score data to evaluate the non-inferiority in the adhesion of test formulation to the reference formulation. Bioequivalence was determined by a statistical comparison of Cmax, AUCt and AUCi for the test and reference products for Rotigotine. To demonstrate adhesiveness, the 90% confidence interval of mean adherence for the test product at the end of the dosing interval was to be lie above 90%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- evaluator-blinded, randomized, two-period, two-treatment, crossover, balanced, single dose.
| Arm | Type | Receives |
|---|---|---|
| Test / Reference | Other | Combination Product: Rotigotine Transdermal Delivery System (TDS)Rotigotina B7 TDS (Test) / Neupro® (Reference) |
| Reference / Test | Other | Combination Product: Rotigotine Transdermal Delivery System (TDS)Neupro® (Reference) / Rotigotina B7 TDS (Test) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first patch application. They must be using an acceptable form of contraception.
- BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- Non-alcoholic (i.e. having no past history of alcohol consumption for at least one year prior to study).
- Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
Key exclusion criteria (47 listed)
- Participants must not be enrolled in the study if they meet any one of the following criteria:
- History of allergic responses to Rotigotine, or any other components of the formulations (Test and/or Reference ones) or other related drugs and/or history of allergy to any adhesive materials.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, gynaecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
- Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History or presence of bronchial asthma.
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 |
|---|---|---|
| Rotigotine Transdermal Delivery System (TDS)Strength: 2 mg/24 hours | Combination product | Reference / Test, Test / Reference |
Primary outcome
Bioequivalence based on Cmax
Time frame: 24 Hours
Peak Plasma Concentration (Cmax) 90% confidence limits of T/R ratio must lie within 80-125 %
Non-Inferiority in Adhesion
Time frame: 24 Hours
The Test patch adhesion 90% LCL must lie above 90%.
Bioequivalence based on AUC 0-t
Time frame: 24 Hours
The area under the plasma concentration versus time curve (AUC 0-t) 90% confidence limits of T/R ratio must lie within 80-125 %
Bioequivalence based on AUCi
Time frame: 24 Hours
The area under the plasma concentration versus time curve extrapolated to infinite (AUC i) 90% confidence limits of T/R ratio must lie within 80-125 %
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided. Legal and/or Ethical as well as Confidential complexities might apply.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rotigotine Transdermal Delivery System (TDS) in people with Bioequivalence and Adhesion, run by Amarin Technologies S.A.U. at 1 site in India.
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 19 inclusion and 47 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Bioequivalence based on Cmax (time frame: 24 Hours). The study lists 4 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 19 Aug 2026.