OtherPhase 1NCT04236921
Bioequivalence Bewteen DopaSnap® (Cabidopa/Levopdoap 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet (Actavis)
A Phase 1 study testing DopaSnap® and RDL of CD-LD in people with Other, run by Riverside Pharmacueticals Corporation at 1 site in Canada.
Trial summary
This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts: Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Other
- What is being tested?
- DopaSnap® and RDL of CD-LD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2019to 1 Dec 2019
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥35 and ≤75 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator.
- the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
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- male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
- hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study;
- sterile male partner (vasectomized since at least 6 months).
- Capable of consent.
Who cannot join
- 1) Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- 2) Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
- 3) History of allergic reactions to carbidopa, levodopa, or other related drugs, or to any excipient in the formulation.
- 4) Positive pregnancy test at screening. 5) Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- 6) History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- 7) History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
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- 8) Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- 9) Use of medication other than topical drug products without significant systemic absorption and hormonal contraceptives:
- prescription medication within 14 days prior to the first dosing;
- over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug within 3 months prior to the first dosing (other than hormonal contraceptives);
- MAO inhibitors within 30 days prior to the first dosing; 10) Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- 11) Hemoglobin < 128 g/L (males) and < 115 g/L (females) and hematocrit < 0.36 L/L (males) and < 0.32 L/L (females) at screening.
- 12) Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- 13) Breast-feeding subject. 14) History or presence of myasthenia gravis. 15) Treatment with centrally active drugs or those affecting peripheral cholinergic transmission within 3 months of screening.
- 16) The presence of history of narrow angle glaucoma. 17) The presence of history of depression, suicidal tendencies, and other psychotic disorders.
- 18) The presence of history of myocardial infarction, arrhythmias, bronchial asthma and other cardiovascular, or pulmonary disease.
- 19) The presence of history of melanoma and suspicious undiagnosed skin lesions.
- 20) The presence of history of neuroleptic malignant syndrome and non-traumatic rhabdomyolysis.
- 21) The presence of history of peptic ulcer disease or undiagnosed recurrent gastro-intestinal bleeding.
- 22) The presence of history of convulsions. 23) HAMD-7 score above 3 at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Bioequivalence Between DopaSnap® (Carbidopa/Levodopa 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet and to Evaluate the Food-Effect of DopaSnap® in Normal Healthy Volunteers
This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
Read the detailed description
This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
- Part I: bioequivalence, food-effect, randomized, open-label, single dose, 3-period, 6-sequence, crossover design.
- Part II: multiple-dose (every 4 hours), open-label, 1-period design.
- Part III: multiple-dose (every 2 hours), open-label, 1-period design.
- Conditions
- Other
- Being tested
- DopaSnap®, RDL of CD-LD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopaSnap®Drug
Also called test product
immediate release CD/LD 25/100mg; Riverside Pharmaceuticals Corporation, USA
RDL of CD-LDDrug
Also called Reference
(immediate release CD/LD 25/100mg; Merck Sharp \& Dohme Corp., USA),
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 1 x DopaSnap® tablet, administered under fasting conditions. Receives: Drug: DopaSnap® |
| Treatment B | Active comparator | 1 x RLD of CD-LD tablet administered under fasting conditions. Receives: Drug: RDL of CD-LD |
| Treatment C | Experimental | Test - fed 1 x DopaSnap® tablet , administered under fed conditions. Receives: Drug: DopaSnap® |
| Treatment D | Experimental | DopaSnap® tablet administered at 0 and 4 hours post-first dose, for a total daily dose of CD/LD 50/200 mg. Receives: Drug: DopaSnap® |
| Treatment E | Experimental | ½ x DopaSnap® tablet administered at 0, 2, 4, and 6 hours post-first dose Receives: Drug: DopaSnap® |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. AUC0-t
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. AUC0-inf
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Cmax
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Residual area
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Tmax
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. T½ el
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
compare the rate and extent of absorption
- to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Kel
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Effect of food on the pharmacokinetics (PK)
PK Parameters: AUC0-t
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
Effect of food on the pharmacokinetics (PK)
PK Parameters: Cmax
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
Effect of food on the pharmacokinetics (PK)
PK Parameters: Tmax
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
Secondary outcomes (3)
PK profile of a fraction of the DopaSnap® tablet
- the PK profile of a fraction of the DopaSnap® tablet when administered at frequent intervals every 2 hours comparing to whole tablet every 4 hours PK Parameters: AUC0-t
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK profile of a fraction of the DopaSnap® tablet
- the PK profile of a fraction of the DopaSnap® tablet when administered at frequent intervals every 2 hours comparing to whole tablet every 4 hours PK Parameters: Tmax
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK profile of a fraction of the DopaSnap® tablet
- the PK profile of a fraction of the DopaSnap® tablet when administered at frequent intervals every 2 hours comparing to whole tablet every 4 hours PK Parameters: Cmax
Measured: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Jul 2019
- Primary completion11 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtherStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- * Part I: bioequivalence, food-effect, randomized, open-label, single-dose, 3-period, 6-sequence, crossover design. * Part II: multiple-dose (every 4 hours), open-label, 1-period design. * Part III: multiple-dose (every 2 hours), open-label, 1-period design. Subjects enrolled in Part II and Part III will be a subset of those who completed Part I.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside Pharmacueticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephane Lamouche, PhD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236921
- Sponsor's protocol ID
- 190051
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Bioequivalence Between DopaSnap® (Carbidopa/Levodopa 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet and to Evaluate the Food-Effect of DopaSnap® in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04236921
- Acronym / sponsor ID
- 190051
- Conditions
- Other
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Riverside Pharmacueticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 22 Jan 2020 (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 will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
Detailed description
This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
- Part I: bioequivalence, food-effect, randomized, open-label, single dose, 3-period, 6-sequence, crossover design.
- Part II: multiple-dose (every 4 hours), open-label, 1-period design.
- Part III: multiple-dose (every 2 hours), open-label, 1-period design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- * Part I: bioequivalence, food-effect, randomized, open-label, single-dose, 3-period, 6-sequence, crossover design. * Part II: multiple-dose (every 4 hours), open-label, 1-period design. * Part III: multiple-dose (every 2 hours), open-label, 1-period design. Subjects enrolled in Part II and Part III will be a subset of those who completed Part I.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: DopaSnap®1 x DopaSnap® tablet, administered under fasting conditions. |
| Treatment B | Active comparator | Drug: RDL of CD-LD1 x RLD of CD-LD tablet administered under fasting conditions. |
| Treatment C | Experimental | Drug: DopaSnap®Test - fed 1 x DopaSnap® tablet , administered under fed conditions. |
| Treatment D | Experimental | Drug: DopaSnap®DopaSnap® tablet administered at 0 and 4 hours post-first dose, for a total daily dose of CD/LD 50/200 mg. |
| Treatment E | Experimental | Drug: DopaSnap®½ x DopaSnap® tablet administered at 0, 2, 4, and 6 hours post-first dose |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥35 and ≤75 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- Capable of consent.
Key exclusion criteria (21 listed)
- 1) Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- 2) Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
- 3) History of allergic reactions to carbidopa, levodopa, or other related drugs, or to any excipient in the formulation.
- 4) Positive pregnancy test at screening. 5) Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- 6) History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
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 |
|---|---|---|
| DopaSnap®Also: test productimmediate release CD/LD 25/100mg; Riverside Pharmaceuticals Corporation, USA | Drug | Treatment A, Treatment C, Treatment D, Treatment E |
| RDL of CD-LDAlso: Reference(immediate release CD/LD 25/100mg; Merck Sharp \& Dohme Corp., USA), | Drug | Treatment B |
Primary outcome
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. AUC0-t
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. AUC0-inf
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Cmax
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Residual area
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Tmax
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. T½ el
compare the rate and extent of absorption
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
• to compare the rate and extent of absorption of the immediate-release CD/LD 25/100 mg DopaSnap® tablet (Test) versus the immediate-release CD-LD tablet (Reference), each administered orally as a single tablet under fasting conditions. Kel
Effect of food on the pharmacokinetics (PK)
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK Parameters: AUC0-t
Effect of food on the pharmacokinetics (PK)
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK Parameters: Cmax
Effect of food on the pharmacokinetics (PK)
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK Parameters: Tmax
3 secondary outcomes
PK profile of a fraction of the DopaSnap® tablet
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK profile of a fraction of the DopaSnap® tablet
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
PK profile of a fraction of the DopaSnap® tablet
Time frame: A total of 25 blood samples will be collected: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, and 12 hours post-first dose.
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 22 Jan 2020.
- 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.
Stephane Lamouche, PhD principal investigator
Syneos Health
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 DopaSnap® and RDL of CD-LD in people with Other, run by Riverside Pharmacueticals Corporation at 1 site 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 10 inclusion and 21 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 22 Jan 2020. 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 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?
compare the rate and extent of absorption (time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.). The study lists 10 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 22 Jan 2020.