Chronic PainPhase 1NCT03398330

OTR Tablet 40 mg Fed-state Bioequivalence Study

A Phase 1 study testing Oxycodone Tamper Resistant and OxyContin® in people with Chronic Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Chronic Pain
What is being tested?: Oxycodone Tamper Resistant and OxyContin®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteChina
Study dates: 16 Mar 2017to 6 Nov 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult

Who may be able to join

Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
The average pain over the last 24 hours should be scored < 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition has been kept stable at least in the past 7 days prior to entering into the screening and is expected to be stable during the study duration
Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
Karnofsky score of Performance Status ≥70
Willing to take all the food supplied while the subject is in the study unit
Be able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and be willing to follow the protocol requirements
Willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, some Intrauterine Device (IUD), sexual abstinence, or vasectomised partner
Female subjects, including those up to less than one year post-menopausal, must have a negative serum pregnancy test and be non-lactating

Who cannot join

Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
Have hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR and OXYCONTIN tablet Summary of Product Characteristics
Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency
Subjects with respiratory depression, corpulmonale, or chronic bronchial asthma

Show all 22Show fewer

Any history of seizures or symptomatic head trauma
Subjects with abnormal liver function (values exceeding the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin during the Screening Phase) or abnormal renal function (values exceeding the ULN for serum creatinine during the Screening Phase). Note: if the values of ALT, AST or total bilirubin are between 1 to 1.2 times of ULN and confirmed not clinically significant by the Investigators, the subject may be recruited after getting the approval from Sponsor.
Any other significant illness other than the primary disease of chronic pain during the 4 weeks preceding the entry into this study
Subjects who are unable to stop taking monoamine oxidase inhibitors during this trial period or time lapses less than 2 weeks since drug withdrawal prior to the study drug administration
Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the study drug administration
Subjects who have used any medicinal product which inhibits Cytochrome P450 3A4 (CYP3A4) (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin, etc.) within 4 weeks prior to the study drug administration
Subjects who have used any medicinal product which inhibits Cytochrome P450 2D6 (CYP2D6) (e.g. fluoxetine, quinidine, ritonavir, etc.) or induces CYP2D6 (e.g. dexamethasone, rifampicin, glutethimide, etc.) within 4 weeks prior to the study drug administration
Histories of smoking (being a smoker or an occasional smoker) within 45 days prior to the study drug administration and refusal to abstain from smoking during the study. According to World Health Organization (WHO), a smoker is defined as having smoked at least 1 cigarette per day continuously for more than 6 months and an occasional smoker is defined as having smoked for more than 4 times per week and less than 1 cigarette per day continuously for more than 6 months.
Subjects with histories of alcoholism or drug abuse. Alcoholism is defined as regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)
Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol for at least 48 hours after study drug administration
Refusal to abstain from food for 10 hours preceding and 4 hours following administration of the study drug and to abstain from caffeine or xanthine entirely during each confinement
Positive Hepatitis B Surface Antigen (HBsAg), anti-Hepatitis C Virus (HCV), anti-Human Immunodeficiency Virus (HIV), or syphilis antibody test result
Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids. Or alcohol breath test is positive
Any history of frequent nausea or emesis regardless of aetiology
Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol
Subjects who participated in a clinical research study within 30 days of study entry

Trial locations and contacts

1 site in 1 country.

China1 site

Xiangya Hospital of Central South University
Changsha, Hunan, 410008

Other trials in China

About this study

Official title: An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fed State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain

An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain.

Read the detailed description

The investigation is designed as an open-label, single dose, randomized, and cross-over study to determine the pharmacokinetics(PK) profile of oxycodone from OTR tablet 40 mg and OXYCONTIN tablet 40 mg in Chinese subjects with chronic pain in a fed stat.

Subjects with histories of chronic pain are chosen as the target population. Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data.

Conditions: Chronic Pain
Being tested: Oxycodone Tamper Resistant, OxyContin®
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone Tamper ResistantDrug
Also called Oxycodone Tamper Resistant (OTR) Tablet
Orally taking Oxycodone Tamper Resistant 40mg in fed state
OxyContin®Drug
Also called OXYCONTIN® Tablet 40 mg
Orally taking OXYCONTIN® 40mg in fed state

Study groups in NCT03398330
Study group	Role	What they receive
Oxycodone Tamper Resistant	Experimental	Oxycodone Tamper Resistant (OTR) Tablet 40 mg Receives: Drug: Oxycodone Tamper Resistant
OXYCONTIN®	Active comparator	OXYCONTIN® Tablet 40 mg Receives: Drug: OxyContin®

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Measured: up to 32 hours
AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Measured: up to 32 hours
AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.
Measured: up to 32 hours

Secondary outcomes (5)

Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State
An overall summary of the number and percentage of Adverse Events will be provided for each treatment groups to assess the safety of OTR tablet 40 mg and OXYCONTIN® tablet 40 mg.
Measured: up to 35 days
Number of Lab Tests With Clinical Significance
Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Measured: up to 35 days
Number of AEs Related to Vital Signs
Vital sign parameters to be summarised include systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature.Vital sign results for each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N), or higher than (H) the reference range for that parameter. Vital sign results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Measured: up to 35 days
Number of AEs Related to ECGs
Summarized table of 12-lead ECG is presented. ECG was measured at Screening and 4 days after IMP dosing in Period 2.
Measured: up to 35 days
Number of AEs Related to Physical Examination
Physical examination were measured at Screening, 1 day before IMP dosing and 4 days after IMP dosing in each period.
Measured: up to 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20176 Nov 2017

First posted12 Jan 2018
Study start16 Mar 2017
Primary completion5 Sep 2017
Study completion6 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03398330
Sponsor's protocol ID: ONF16-CN-103
Status last verified: Nov 2019
First submitted: 26 Jul 2016
Last updated: 15 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fed State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain
ClinicalTrials.gov ID: NCT03398330
Acronym / sponsor ID: ONF16-CN-103
Conditions: Chronic Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: 16 Mar 2017 (actual)
Primary completion: 5 Sep 2017 (actual)
Study completion: 6 Nov 2017 (actual)
First posted: 12 Jan 2018 (actual)
Results: Posted 15 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain.

Detailed description

Subjects with histories of chronic pain are chosen as the target population. Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oxycodone Tamper Resistant	Experimental	Drug: Oxycodone Tamper ResistantOxycodone Tamper Resistant (OTR) Tablet 40 mg
OXYCONTIN®	Active comparator	Drug: OxyContin®OXYCONTIN® Tablet 40 mg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
The average pain over the last 24 hours should be scored < 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition has been kept stable at least in the past 7 days prior to entering into the screening and is expected to be stable during the study duration
Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
Karnofsky score of Performance Status ≥70
Willing to take all the food supplied while the subject is in the study unit

Key exclusion criteria (22 listed)

Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
Have hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR and OXYCONTIN tablet Summary of Product Characteristics
Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency

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
Oxycodone Tamper ResistantAlso: Oxycodone Tamper Resistant (OTR) TabletOrally taking Oxycodone Tamper Resistant 40mg in fed state	Drug	Oxycodone Tamper Resistant
OxyContin®Also: OXYCONTIN® Tablet 40 mgOrally taking OXYCONTIN® 40mg in fed state	Drug	OXYCONTIN®

Primary outcome

Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
Time frame: up to 32 hours
The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
Time frame: up to 32 hours
The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
Time frame: up to 32 hours
The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.

5 secondary outcomes

Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State
Time frame: up to 35 days
Number of Lab Tests With Clinical Significance
Time frame: up to 35 days
Number of AEs Related to Vital Signs
Time frame: up to 35 days
Number of AEs Related to ECGs
Time frame: up to 35 days
Number of AEs Related to Physical Examination
Time frame: up to 35 days

Results and safety

Results posted to the registry on 15 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTR 40 Mg-OXYCONTIN 40 mg	21	20
OXYCONTIN 40 Mg-OTR 40 mg	21	17

Primary outcome: Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

Time frame: up to 32 hours. Mean (90% Confidence Interval). Unit: ng/ml

Measure	Cmax of OTR Tablet 40 mg n = 37	Cmax of OXYCONTIN Tablet 40 mg n = 36
Value	86.15 (67.895 to 104.405)	63.54 (50.035 to 77.045)

Primary outcome: AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

Time frame: up to 32 hours. Mean (90% Confidence Interval). Unit: ng*h/ml

Measure	AUCt of OTR Tablet 40 mg n = 37	AUCt of OXYCONTIN Tablet 40 mg n = 36
Value	641.3017 (517.97802 to 764.62538)	646.2133 (514.12207 to 778.30453)

Primary outcome: AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

Time frame: up to 32 hours. Mean (90% Confidence Interval). Unit: ng*h/ml

Measure	AUCINF of OTR Tablet 40 mg n = 37	AUCINF of OXYCONTIN Tablet 40 mg n = 36
Value	648.2546 (521.43808 to 775.07112)	664.0493 (521.26837 to 806.8302)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTR 40mg	1 of 37 (2.7%)	5 of 37 (13.5%)	0 of 37
OXYCONTIN® 40mg	0 of 40 (0%)	10 of 40 (25%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Pingsheng Xu, Master principal investigator

Xiangya Hospital of Central South University

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 Oxycodone Tamper Resistant and OxyContin® in people with Chronic Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

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 8 inclusion and 22 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 15 Nov 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 China. 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?

Yes. Results are posted in the registry (first posted 15 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State (time frame: up to 32 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03398330.

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 15 Nov 2019; AzTrials last refreshed its copy on 29 Oct 2026.