HealthyPhase 1NCT02618395
Bioavailability Study of SPARC001 in Healthy Adult Volunteers
A Phase 1 study testing SPARC001A, SPARC001B and Reference001 - Hydrocodone in people with Healthy, run by Sun Pharma Advanced Research Company Limited.
Trial summary
Bioavailability study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SPARC001A, SPARC001B and Reference001 - Hydrocodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2015to 25 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult, male and female volunteers, 18 to 55 years of age
- Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
- Female subjects must have a negative serum pregnancy test
- Medically healthy on the basis of medical history and physical examination
Who cannot join
- Females who are pregnant, lactating, or likely to become pregnant during the study
- Life-time history and/or recent evidence of alcohol
- History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
- Subjects with any condition in which an opioid is contraindicated
About this study
Bioavailability study
Read the detailed description
Bioavailability, safety and tolerability
- Conditions
- Healthy
- Being tested
- SPARC001A, SPARC001B, Reference001 - Hydrocodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC001ADrug
SPARC001BDrug
Reference001 - HydrocodoneDrug
Hydrocodone-acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: SPARC001A |
| Treatment B | Experimental | Not described Receives: Drug: SPARC001B |
| Treatment C | Experimental | Not described Receives: Drug: Reference001 - Hydrocodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
Measured: 17 days
Secondary outcomes (4)
AUC extrapolated to infinity (AUC0 ∞)
Measured: 17 days
Time to Cmax (tmax)
Measured: 17 days
Elimination half-life (t½)
Measured: 17 days
Treatment emergent adverse event
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start28 Dec 2015
- Primary completion25 Jan 2016
- Study completion25 Jan 2016
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02618395
- Sponsor's protocol ID
- SUN-HBA-PK001
- Status last verified
- May 2019
- First submitted
- 23 Nov 2015
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of SPARC001 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02618395
- Acronym / sponsor ID
- SUN-HBA-PK001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 1 Dec 2015 (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.
Bioavailability study
Detailed description
Bioavailability, safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: SPARC001A |
| Treatment B | Experimental | Drug: SPARC001B |
| Treatment C | Experimental | Drug: Reference001 - Hydrocodone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, male and female volunteers, 18 to 55 years of age
- Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
- Female subjects must have a negative serum pregnancy test
- Medically healthy on the basis of medical history and physical examination
Key exclusion criteria (4 listed)
- Females who are pregnant, lactating, or likely to become pregnant during the study
- Life-time history and/or recent evidence of alcohol
- History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
- Subjects with any condition in which an opioid is contraindicated
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 |
|---|---|---|
| SPARC001A | Drug | Treatment A |
| SPARC001B | Drug | Treatment B |
| Reference001 - HydrocodoneHydrocodone-acetaminophen | Drug | Treatment C |
Primary outcome
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
Time frame: 17 days
4 secondary outcomes
AUC extrapolated to infinity (AUC0 ∞)
Time frame: 17 days
Time to Cmax (tmax)
Time frame: 17 days
Elimination half-life (t½)
Time frame: 17 days
Treatment emergent adverse event
Time frame: 17 days
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 3 May 2019.
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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 SPARC001A, SPARC001B and Reference001 - Hydrocodone in people with Healthy, run by Sun Pharma Advanced Research Company Limited.
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 4 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 3 May 2019. 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?
Maximum plasma hydrocodone and acetaminophen concentration (Cmax) (time frame: 17 days). 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 3 May 2019.