PainPhase 1NCT00802087
Single Dose Pharmacokinetics of Egalet® Hydrocodone
A Phase 1 study testing hydrocodone and hydrocodone & acetaminophen combination in people with Pain, run by Egalet Ltd at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- hydrocodone and hydrocodone & acetaminophen combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Apr 2009
- 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-smokers
- ≥18 and ≤55 years of age
- BMI ≥19 and ≤30.0
Who cannot join
- Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
- History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
- Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.
Read the detailed description
Outcomes:
Pharmacokinetic parameters and bioequivalence testing.
- Conditions
- Pain
- Being tested
- hydrocodone, hydrocodone & acetaminophen combination
- Keywords
- Hydrocodone, Pharmacokinetics, Safety & Tolerability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocodoneDrug
Extended Release tablet
hydrocodone & acetaminophen combinationDrug
Immediate Release tablet, hydrocodone and acetaminophen combination product
| Study group | Role | What they receive |
|---|---|---|
| Egalet® hydrocodone treatment A | Experimental | Single Dose administration Receives: Drug: hydrocodone |
| Egalet® hydrocodone Treatment B | Experimental | Single Dose Administration Receives: Drug: hydrocodone |
| Egalet® hydrocodone Treatment C | Experimental | Single Dose Administration Receives: Drug: hydrocodone |
| Egalet® hydrocodone Treatment D | Experimental | Single Dose Administration Receives: Drug: hydrocodone |
| Active Comparator | Active comparator | Single Dose Administration Receives: Drug: hydrocodone & acetaminophen combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
Measured: Single-dose evaluation
Secondary outcomes (1)
To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.
Measured: Single-dose evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Andersen, M.Sc.Pharm, Study director, Egalet A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802087
- Sponsor's protocol ID
- HC-EG-001
- Status last verified
- Aug 2016
- First submitted
- 2 Dec 2008
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00802087
- Acronym / sponsor ID
- HC-EG-001
- Conditions
- Pain
- Keywords
- Hydrocodone, Pharmacokinetics, Safety & Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Dec 2008 (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 purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.
Detailed description
Outcomes:
Pharmacokinetic parameters and bioequivalence testing.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Egalet® hydrocodone treatment A | Experimental | Drug: hydrocodoneSingle Dose administration |
| Egalet® hydrocodone Treatment B | Experimental | Drug: hydrocodoneSingle Dose Administration |
| Egalet® hydrocodone Treatment C | Experimental | Drug: hydrocodoneSingle Dose Administration |
| Egalet® hydrocodone Treatment D | Experimental | Drug: hydrocodoneSingle Dose Administration |
| Active Comparator | Active comparator | Drug: hydrocodone & acetaminophen combinationSingle Dose Administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smokers
- ≥18 and ≤55 years of age
- BMI ≥19 and ≤30.0
Key exclusion criteria (5 listed)
- Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
- History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
- Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
- Pregnant or breast-feeding
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 |
|---|---|---|
| hydrocodoneExtended Release tablet | Drug | Egalet® hydrocodone Treatment B, Egalet® hydrocodone Treatment C, Egalet® hydrocodone Treatment D, Egalet® hydrocodone treatment A |
| hydrocodone & acetaminophen combinationImmediate Release tablet, hydrocodone and acetaminophen combination product | Drug | Active Comparator |
Primary outcome
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
Time frame: Single-dose evaluation
1 secondary outcome
To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.
Time frame: Single-dose evaluation
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 Aug 2016.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Christine Andersen, M.Sc.Pharm study director
Egalet A/S
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 hydrocodone and hydrocodone & acetaminophen combination in people with Pain, run by Egalet Ltd 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 3 inclusion and 5 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 Aug 2016. 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?
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24 (time frame: Single-dose evaluation). 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 Aug 2016.