HealthyPhase 1NCT02991261
Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
A Phase 1 study testing SPARC001 type I, SPARC001 type II and Reference001 type I in people with Healthy, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female 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
- What is being tested?
- SPARC001 type I, SPARC001 type II and Reference001 type I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 1 Apr 2017
- 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
- Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
- Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight >50 kg (110 lbs) at Screening
- All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
- Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.
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 or drug/substance abuse disorder
- Subjects who need to maintain mental alertness throughout the study
- Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
- Conditions
- Healthy
- Being tested
- SPARC001 type I, SPARC001 type II, Reference001 type I, Reference001 type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC001 type IDrug
Treatment type I
SPARC001 type IIDrug
Treatment type II
Reference001 type IDrug
Hydrocodone-acetaminophen
Reference001 type IIDrug
Hydrocodone Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| SPARC001 type I | Experimental | Treatment type I Receives: Drug: SPARC001 type I; Drug: SPARC001 type II; Drug: Reference001 type I; Drug: Reference001 type II |
| SPARC001 type II | Experimental | Treatment type II Receives: Drug: SPARC001 type I; Drug: SPARC001 type II; Drug: Reference001 type I; Drug: Reference001 type II |
| Reference001 type I | Active comparator | Hydrocodone-Acetaminophen Receives: Drug: SPARC001 type I; Drug: SPARC001 type II; Drug: Reference001 type I; Drug: Reference001 type II |
| Reference type II | Active comparator | Hydrocodone-Acetaminophen Receives: Drug: SPARC001 type I; Drug: SPARC001 type II; Drug: Reference001 type I; Drug: Reference001 type II |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: 48 hours
Cmax
Measured: 48 hours
Secondary outcomes (1)
Adverse event
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start6 Feb 2017
- Primary completion15 Mar 2017
- Study completion1 Apr 2017
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
- None (open label)
- Enrolment
- 24 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
- NCT02991261
- Sponsor's protocol ID
- CLR_16_29
- Status last verified
- May 2019
- First submitted
- 8 Dec 2016
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
- A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
- ClinicalTrials.gov ID
- NCT02991261
- Acronym / sponsor ID
- CLR_16_29
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 13 Dec 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.
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPARC001 type I | Experimental | Drug: SPARC001 type I, Drug: SPARC001 type II, Drug: Reference001 type I, Drug: Reference001 type IITreatment type I |
| SPARC001 type II | Experimental | Drug: SPARC001 type I, Drug: SPARC001 type II, Drug: Reference001 type I, Drug: Reference001 type IITreatment type II |
| Reference001 type I | Active comparator | Drug: SPARC001 type I, Drug: SPARC001 type II, Drug: Reference001 type I, Drug: Reference001 type IIHydrocodone-Acetaminophen |
| Reference type II | Active comparator | Drug: SPARC001 type I, Drug: SPARC001 type II, Drug: Reference001 type I, Drug: Reference001 type IIHydrocodone-Acetaminophen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
- Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight >50 kg (110 lbs) at Screening
- All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
- Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.
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 or drug/substance abuse disorder
- Subjects who need to maintain mental alertness throughout the study
- Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
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 |
|---|---|---|
| SPARC001 type ITreatment type I | Drug | Reference type II, Reference001 type I, SPARC001 type I, SPARC001 type II |
| SPARC001 type IITreatment type II | Drug | Reference type II, Reference001 type I, SPARC001 type I, SPARC001 type II |
| Reference001 type IHydrocodone-acetaminophen | Drug | Reference type II, Reference001 type I, SPARC001 type I, SPARC001 type II |
| Reference001 type IIHydrocodone Acetaminophen | Drug | Reference type II, Reference001 type I, SPARC001 type I, SPARC001 type II |
Primary outcome
AUC
Time frame: 48 hours
Cmax
Time frame: 48 hours
1 secondary outcome
Adverse event
Time frame: 25 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.
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 SPARC001 type I, SPARC001 type II and Reference001 type I in people with Healthy, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
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.
Where is the study taking place?
The record lists 1 site in United States. 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?
AUC (time frame: 48 hours). 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 3 May 2019.