CompletedNCT03403504Updated Jan 31, 2020Results posted

OTR Tablet 10 mg Fasted-state Bioequivalence Study

A Phase 1 interventional study of Oxycodone Tamper Resistant and OXYCONTIN® in Chronic Pain, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd (part of Mundipharma) · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This is an open-label, single Dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted 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 PK profile of oxycodone from OTR tablet 10 mg and OXYCONTIN tablet 10 mg in Chinese subjects with chronic pain in a fasted state.

the China regulations for drug registration require that controlled medicine (opioid is categorized to be a controlled medicine) should not be applied in healthy volunteers in clinical studies. In this BE study, 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. The subjects with abnormal liver and kidney functions, which may affect the metabolism of oxycodone.

As a general rule, cross-over design is applied in the study to decrease the inter-individual variations between the two cohorts. A washout period lasting for at least 7 half-lives of the investigational medicine is needed to eliminate the drug residual from the previous period

open label design is applied since the plasma concentration of oxycodone is to be objectively tested and analysed and randomization will be applied to reduce selection bias.

Conditions studied

Chronic Pain

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In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

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Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 (BMI) ≥18 and ≤28 kg/m2
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 Form (ICF) prior to study participation and be willing to follow the protocol requirements
Willing to use adequate and highly effective methods of 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 , must have a negative serum pregnancy test and be non-lactating.

Exclusion criteria

Exclusion Criteria:

Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
Have history to any opioids, naltrexone, naloxone, or related compounds or any 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
Any history of seizures or symptomatic head trauma
Subjects with abnormal liver function (values exceeding the (ULN) for (ALT), aspartate aminotransferase (AST), or total 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 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 () (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induces CYP3A4 (e.g. , 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 Surface Antigen (HBsAg), anti- Virus (HCV), anti- (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

Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Oxycodone Tamper Resistant
Oxycodone Tamper Resistant (OTR) Tablet 10 mg
Drug: Oxycodone Tamper Resistant
Active comparator
OXYCONTIN®
OXYCONTIN® Tablet 10 mg
Drug: OXYCONTIN®

Interventions

DrugOxycodone Tamper Resistant
Orally administered Oxycodone Tamper Resistant 10mg
Also known as: Oxycodone Tamper Resistant (OTR) Tablet 10 mg
DrugOXYCONTIN®
Orally administered OXYCONTIN® Tablet 10 mg
Also known as: OXYCONTIN® Tablet 10 mg

What researchers measure

Primary outcomes

Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.
Time frame: up to 32 hours
AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.
Time frame: up to 32 hours
AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.
Time frame: up to 32 hours

Secondary outcomes

Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted 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 10 mg and OXYCONTIN tablet 10 mg.
Time frame: up to 35 days
Number of AEs Related to Vital Signs
Vital sign parameters( systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature)to be summarised on the rate of lower than, within, and higher than the reference range values from baseline to end of study.
Time frame: up to 35 days
Number of AEs Related to ECGs
Twelve-lead ECG was conducted at screening and on Day 4 of Period 2.
Time frame: up to 35 days
Number of Lab Tests With Clinical Significance
Clinical laboratory data (hematology, blood chemistry, and urinalysis) to be summarized on the rate of lower than, within, and higher than the reference range values from baseline to end of study.
Time frame: up to 35 days
Number of AEs Related to Physical Examination
Physical examination was conducted at screening, and on Day -1, Day 4 in each Period.
Time frame: up to 35 days

Results

Posted Oct 31, 2019

Participant flow

24, from Mar2017 to Jul2017, from patient database, medical clinic, advertisement recruitment and etc.

Period 1

Participant flow — Period 1
Milestone	OXYCONTIN 10 mg - OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg
Started	12	12
Completed	12	11
Not completed	0	1

Period 2

Participant flow — Period 2
Milestone	OXYCONTIN 10 mg - OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg
Started	12	11
Completed	12	11
Not completed	0	0

Outcome measures

PrimaryCmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.

Time frame:: up to 32 hours
Reported as:: Mean · ng/ml

Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
ng/ml	Cmax of OTR 10 mg	Cmax of OXYCONTIN 10 mg
Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	11.617 (8.5821 to 14.6519)	10.564 (8.3103 to 12.8177)

PrimaryAUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.

Time frame:: up to 32 hours
Reported as:: Mean · ng*h/ml

AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
ng*h/ml	AUCt of OTR Tablet 10 mg	AUCt of OXYCONTIN Tablet 10 mg
AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	123.5608 (93.4687 to 153.6529)	124.0294 (98.1652 to 149.8936)

PrimaryAUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted 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.

Time frame:: up to 32 hours
Reported as:: Mean · ng*h/ml

AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
ng*h/ml	AUCINF of OTR Tablet 10 mg	AUCINF of OXYCONTIN Tablet 10 mg
AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	125.7605 (94.4572 to 157.0638)	127.4811 (100.0286 to 154.9336)

SecondaryAdverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted 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 10 mg and OXYCONTIN tablet 10 mg.

Time frame:: up to 35 days
Reported as:: Number · AEs

Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
AEs	Adverse Events of OTR Tablet 10 mg	Adverse Events of OXYCONTIN Tablet 10 mg
Number of AEs	17	13
Number of TEAEs	17	13
Number of related TEAEs	8	6

SecondaryNumber of AEs Related to Vital Signs

Vital sign parameters( systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature)to be summarised on the rate of lower than, within, and higher than the reference range values from baseline to end of study.

Time frame:: up to 35 days
Reported as:: Number · AEs of vital signs related

Number of AEs Related to Vital Signs
AEs of vital signs related	Vital Signs of OTR Tablet 10 mg	Vital Signs of OXYCONTIN Tablet 10 mg
Number of AEs Related to Vital Signs	7	5

SecondaryNumber of AEs Related to ECGs

Twelve-lead ECG was conducted at screening and on Day 4 of Period 2.

Time frame:: up to 35 days
Reported as:: Number · AEs related to ECGs

Number of AEs Related to ECGs
AEs related to ECGs	ECG of OTR Tablet 10 mg	ECG of OXYCONTIN Tablet 10 mg
Number of AEs Related to ECGs	0	0

SecondaryNumber of Lab Tests With Clinical Significance

Clinical laboratory data (hematology, blood chemistry, and urinalysis) to be summarized on the rate of lower than, within, and higher than the reference range values from baseline to end of study.

Time frame:: up to 35 days
Reported as:: Number · lab tests with clinical significance

Number of Lab Tests With Clinical Significance
lab tests with clinical significance	Clinical Laboratory Data of OTR Tablet 10 mg	Clinical Laboratory Data of OXYCONTIN Tablet 10 mg
Number of Lab Tests With Clinical Significance	6	3

SecondaryNumber of AEs Related to Physical Examination

Physical examination was conducted at screening, and on Day -1, Day 4 in each Period.

Time frame:: up to 35 days
Reported as:: Number · AEs related to physical examinations

Number of AEs Related to Physical Examination
AEs related to physical examinations	Physical Examinations of OTR Tablet 10 mg	Physical Examinations of OXYCONTIN Tablet 10 mg
Number of AEs Related to Physical Examination	0	0

Adverse events

Collected over 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. AE data has been collected for 35 days since ICF signed up to follow-up visit for study completion of each subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OTR 10 mg	0/23 (0%)	0/23 (0%)	7/23 (30.4%)
OXYCONTIN 10 mg	0/23 (0%)	0/23 (0%)	0/23 (0%)

Most frequent other events

Most frequent other events
Event	OTR 10 mg	OXYCONTIN 10 mg
Heart rate decreasedCardiac disorders	4/23	0/23
WBC urine positiveRenal and urinary disorders	3/23	0/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
Mean	36.9 ± 10.18	41.6 ± 10.44	39.3 ± 10.36

Sex: Female, Male
Sex: Female, Male(Participants)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
Female	5	5	10
Male	7	7	14

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
HAN	10	12	22
Other	2	0	2

Weight
Weight(kg)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
Mean	68.29 ± 11.462	64.25 ± 9.536	66.27 ± 10.516

Height
Height(cm)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
Mean	169.3 ± 8.11	167.9 ± 5.70	168.6 ± 6.89

BMI
BMI(kg/m2)	OXYCONTIN 10 Mg-OTR 10 mg	OTR 10 Mg-OXYCONTIN 10 mg	Total
Mean	23.72 ± 2.888	22.76 ± 2.974	23.24 ± 2.908

Study locations

1 site

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China

References and documents

Study documents

Study protocol ↗ · May 16, 2016
Statistical analysis plan ↗ · Jan 30, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — There is not a plan to make IPD available

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03403504
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Responsible party: Sponsor
First posted: Jan 18, 2018
Start date: Feb 1, 2017
Primary completion: Jul 24, 2017
Completion: Sep 7, 2017
Results posted: Oct 31, 2019
Last update: Jan 31, 2020

Study contacts

Wenping Wang

principal investigator · First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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