HealthyPhase 1NCT03567941
To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen
A Phase 1 study testing Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2 and Reference in people with Healthy, run by Sun Pharma Advanced Research Company Limited at 1 site in Canada.
Trial summary
Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2 and Reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 29 Dec 2017to 31 Oct 2018
- 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
- Healthy male or female subjects 18 to 55 years of age.
- Opioid users who have used opioids for recreational purposes and or is an avid opioid user.
Who cannot join
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
- Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
- Difficulty swallowing large number of pills.
- Subjects who have had a tattoo or body piercing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions
Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.
- Conditions
- Healthy
- Being tested
- Placebo, Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2, Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablet orally administered under fasting
Hydrocodon bitartrate-acetaminophen arm 1Drug
Tablet orally administered under fasted conditions
Hydrocodon bitartrate-acetaminophen arm 2Drug
Tablet orally administered under fed conditions
ReferenceDrug
Tablet orally administered under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose Receives: Drug: Placebo; Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference |
| Hydrocodon bitartrate-acetaminophen arm 1 | Experimental | Single dose Receives: Drug: Placebo; Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference |
| Hydrocodon bitartrate-acetaminophen arm 2 | Experimental | Single dose Receives: Drug: Placebo; Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference |
| Reference | Active comparator | Single dose Receives: Drug: Placebo; Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking
Visual analog scale on score from 0 to 100
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start29 Dec 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567941
- Sponsor's protocol ID
- CLR_16_07
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2018
- Last updated
- 29 Apr 2019
- Results posted
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions
- ClinicalTrials.gov ID
- NCT03567941
- Acronym / sponsor ID
- CLR_16_07
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 26 Jun 2018 (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.
Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Hydrocodon bitartrate-acetaminophen arm 1, Drug: Hydrocodon bitartrate-acetaminophen arm 2, Drug: ReferenceSingle dose |
| Hydrocodon bitartrate-acetaminophen arm 1 | Experimental | Drug: Placebo, Drug: Hydrocodon bitartrate-acetaminophen arm 1, Drug: Hydrocodon bitartrate-acetaminophen arm 2, Drug: ReferenceSingle dose |
| Hydrocodon bitartrate-acetaminophen arm 2 | Experimental | Drug: Placebo, Drug: Hydrocodon bitartrate-acetaminophen arm 1, Drug: Hydrocodon bitartrate-acetaminophen arm 2, Drug: ReferenceSingle dose |
| Reference | Active comparator | Drug: Placebo, Drug: Hydrocodon bitartrate-acetaminophen arm 1, Drug: Hydrocodon bitartrate-acetaminophen arm 2, Drug: ReferenceSingle dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects 18 to 55 years of age.
- Opioid users who have used opioids for recreational purposes and or is an avid opioid user.
Key exclusion criteria (4 listed)
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
- Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
- Difficulty swallowing large number of pills.
- Subjects who have had a tattoo or body piercing.
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 |
|---|---|---|
| PlaceboTablet orally administered under fasting | Drug | Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2, Placebo, Reference |
| Hydrocodon bitartrate-acetaminophen arm 1Tablet orally administered under fasted conditions | Drug | Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2, Placebo, Reference |
| Hydrocodon bitartrate-acetaminophen arm 2Tablet orally administered under fed conditions | Drug | Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2, Placebo, Reference |
| ReferenceTablet orally administered under fasted conditions | Drug | Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2, Placebo, Reference |
Primary outcome
Drug Liking
Time frame: 15 weeks
Visual analog scale on score from 0 to 100
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 29 Apr 2019.
- 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.
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 Hydrocodon bitartrate-acetaminophen arm 1, Hydrocodon bitartrate-acetaminophen arm 2 and Reference in people with Healthy, run by Sun Pharma Advanced Research Company Limited 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 2 inclusion and 4 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 29 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Drug Liking (time frame: 15 weeks). 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 29 Apr 2019.