Healthy SubjectsPhase 1NCT02713802
Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
A Phase 1 study testing Cudafol(R) (propofol, 1% [10 mg/mL]) and Diprivan(R) (propofol, 1% [10 mg/mL]) in people with Healthy Subjects, run by Cuda Anesthetics, LLC.
Trial summary
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Cudafol(R) (propofol, 1% [10 mg/mL]) and Diprivan(R) (propofol, 1% [10 mg/mL])
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2016
- 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
- Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.
Who cannot join
- Evidence or history of clinically significant disease.
- History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
- Pregnant or nursing (lactating) women.
- Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
- Family history of malignant hyperthermia.
- History of drug or alcohol abuse (or tests positive at screening) or current smoker.
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- Poor venous access in either arm.
- Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.
- Other protocol defined inclusion/exclusion criteria may apply
About this study
Official title: An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Cudafol(R) (propofol, 1% [10 mg/mL]), Diprivan(R) (propofol, 1% [10 mg/mL])
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cudafol(R) (propofol, 1% [10 mg/mL])Drug
Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
Diprivan(R) (propofol, 1% [10 mg/mL])Drug
Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Propofol solution (1% [10 mg/mL]), via intravenous injection Receives: Drug: Cudafol(R) (propofol, 1% [10 mg/mL]) |
| Reference product | Active comparator | Propofol emulsion (1% [10 mg/mL]), via intravenous injection Receives: Drug: Diprivan(R) (propofol, 1% [10 mg/mL]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on pharmacokinetic parameter: Area Under Curve
Measured: 0-24 hours post dose
Bioequivalence based on pharmacokinetic parameter: Cmax
Measured: 0-24 hours post dose
Secondary outcomes (2)
Pharmacokinetic parameter: Tmax
Measured: 0-24 hours post dose
Incidence of adverse events and tolerability
Number of adverse events and local tolerability
Measured: 7 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuda Anesthetics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713802
- Sponsor's protocol ID
- CUDA-C2015-001
- Status last verified
- Apr 2016
- First submitted
- 15 Jan 2016
- Last updated
- 21 Apr 2016
- 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 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02713802
- Acronym / sponsor ID
- CUDA-C2015-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cuda Anesthetics, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Mar 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.
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Cudafol(R) (propofol, 1% [10 mg/mL])Propofol solution (1% [10 mg/mL]), via intravenous injection |
| Reference product | Active comparator | Drug: Diprivan(R) (propofol, 1% [10 mg/mL])Propofol emulsion (1% [10 mg/mL]), via intravenous injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.
Key exclusion criteria (9 listed)
- Evidence or history of clinically significant disease.
- History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
- Pregnant or nursing (lactating) women.
- Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
- Family history of malignant hyperthermia.
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 |
|---|---|---|
| Cudafol(R) (propofol, 1% [10 mg/mL])Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes | Drug | Test product |
| Diprivan(R) (propofol, 1% [10 mg/mL])Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes | Drug | Reference product |
Primary outcome
Bioequivalence based on pharmacokinetic parameter: Area Under Curve
Time frame: 0-24 hours post dose
Bioequivalence based on pharmacokinetic parameter: Cmax
Time frame: 0-24 hours post dose
2 secondary outcomes
Pharmacokinetic parameter: Tmax
Time frame: 0-24 hours post dose
Incidence of adverse events and tolerability
Time frame: 7 days post 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 21 Apr 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cudafol(R) (propofol, 1% [10 mg/mL]) and Diprivan(R) (propofol, 1% [10 mg/mL]) in people with Healthy Subjects, run by Cuda Anesthetics, LLC.
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 1 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 pharmacokinetic parameter: Area Under Curve (time frame: 0-24 hours post dose). 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 21 Apr 2016.