OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Mo... | NCT02880475

NCT02880475

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OXN prolonged release tablet 5/2.5mg	Experimental	The subjects were randomized to receive a single dose of OXN prolonged release tablet 5/2.5mg for one time.	Drug: OXN PR tablet
OXN prolonged release tablet 20/10mg	Experimental	The subjects were randomized to receive a single dose of OXN prolonged release tablet 20/10 mg for one time.	Drug: OXN PR tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OXN PR tablet	Drug	Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg	OXN prolonged release tablet 20/10mg OXN prolonged release tablet 5/2.5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC0-48hr of Noroxycodone Plasma Concentration.	AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.	Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.
AUC0-t of Noroxycodone Plasma Concentration	AUC0-t of Noroxycodone plasma concentration.Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed .(If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis. )	Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.
AUC_%Extrap of Noroxycodone Plasma Concentration	AUC_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.	Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Noroxycodone Plasma Concentration	AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.	Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Noroxycodone Plasma Concentration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Chinese patients with moderate to severe chronic non-malignant pain.
Male and female subjects with age range 18 to 65 years (including 18 and 65), body weight ≥ 45kg and BMI range 18 to 30 (including 18 and 30).
Patients who should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
Patients, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
Females of childbearing potential and less than one year post-menopausal must have a negative serum pregnancy test during screening visit and at check-in and be non-lactating. In addition, they must be willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomised partner.

Exclusion Criteria:

Females who are pregnant (positive β-human chorionic gonadotrophin [HCG] test) or lactating.
Use of opioid or opioid antagonist-containing medication in the 30 days before the start of the study.
Known sensitivity to oxycodone, naloxone, or related compounds.
Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention (medication or surgical) or renal artery stenosis, or any other medical condition, that, in the opinion of the investigator or the sub-investigator, precludes entry into this study.
Subject who have a past (within 5 years) history of malignant neoplasm including leukemia and lymphoma.
The electrocardiogram examination results are abnormal, in the opinion of the investigator or the sub-investigator, and are clinical significance.
Subjects with abnormal liver function (values exceed the upper limit of normal for AST, ALT or total bilirubin during the Screening Period) or abnormal renal function (values exceed the upper limit of normal for serum creatinine during the Screening Period).
Patients with a contraindication to the study medication.
Subjects who have a psychiatric disorder such that participation in the study may, in the opinion of the investigator or the sub-investigator, pose an unacceptable risk to the subject.
Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors.
Subjects with uncontrolled seizures or convulsive disorder.
Subjects who will receive any interventional therapy (surgery, paracentesis,etc) for arthritis during the study period.
History of or any current conditions that might have interfered with drug absorption, distribution, metabolism or excretion.
Any history of frequent nausea or emesis regardless of aetiology.
Participation in any clinical drug study during the 3 months preceding the initial dose in this study.
Use of any medication including vitamins, herbal and/or mineral supplements during the course of the study, other than Vitamin D, calcium supplements and continued use by females of contraceptive medication or HRT.
Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol until at least 48 hours after the last study drug administration.
Blood or blood products donated within 90 days prior to study drug administration or anytime during the study, except as required by this protocol.
Positive results of urine drug screen(for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids), alcohol breath test, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Ab), human immunodeficiency virus (HIV) test or qualitative syphilis tests.
Patients with moderate to severe hypohemia (HGB<90g/L during the screening).

Contacts/Locations Module

Name	Affiliation	Role
Victoria YU	Mundipharma (China) Pharmaceutical Co. Ltd	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100032	China

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	OXN Prolonged Release Tablet 5/2.5 mg	The subjects were randomized to receive a single dose of OXN prolonged release tablets 5/2.5mg for one time. OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg
FG001	OXN Prolonged Release Tablet 20/10 mg	The subjects were randomized to receive a single dose of OXN prolonged release tablets 20/10mg for one time. OXN PR tablet: Orally administered OXN PR tablet 20/10 mg

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00117 subjects
COMPLETED		FG00013 subjects FG00117 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	OXN PR Tablet 5/2.5 mg	The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time. OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
BG001	OXN PR Tablet 20/10 mg

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

AUC0-48hr of Noroxycodone Plasma Concentration.

AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.

12 subjects in OXN PR tablet 5/2.5 mg group,12 subjects in OXN PR tablet 20/10 mg group.

Posted

Mean

Standard Deviation

hr*ng/mL

Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.

ID	Title	Description
OG000	OXN PR Tablet 5/2.5 mg	The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time. OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	OXN PR Tablet 5/2.5 mg	The subjects will be randomized to receive either a single dose of OXN prolonged release tablets 5/25mg, 20/10 mg for one time. OXN PR tablet: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypertriglyceridemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Junjiao Ma	Mundipharma (China) Pharmaceutical Co. , Ltd	01065636711		Junjiao.Ma@mundipharma.com.cn

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 25, 2014	Mar 5, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 1, 2017	Mar 5, 2018	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D059350	Chronic Pain

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.

EG0001 events1 affected13 at risk
EG0010 events0 affected17 at risk

EG0002 events2 affected13 at risk

EG0011 events1 affected17 at risk