Trial Outcomes & Findings for OTR Tablet 10 mg Fasted-state Bioequivalence Study (NCT NCT03403504)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

up to 32 hours

Results posted on

2020-01-31

Participant Flow

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

Participant milestones

Participant milestones
Measure	OXYCONTIN 10 mg - OTR 10 mg the treatment sequence is OXYCONTIN 10 mg dose first and then OTR 10 mg dose in fasted state	OTR 10 Mg-OXYCONTIN 10 mg the treatment sequence is OTR 10 mg dose first and then OXYCONTIN 10 mg dose in fasted state
Period 1 STARTED	12	12
Period 1 COMPLETED	12	11
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	12	11
Period 2 COMPLETED	12	11
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OTR Tablet 10 mg Fasted-state Bioequivalence Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OXYCONTIN 10 Mg-OTR 10 mg n=12 Participants the treatment sequence is OXYCONTIN 10 mg dose first and then OTR 10 mg dose	OTR 10 Mg-OXYCONTIN 10 mg n=12 Participants the treatment sequence is OTR 10 mg dose first and then OXYCONTIN 10 mg dose	Total n=24 Participants Total of all reporting groups
Age, Continuous Mean	36.9 years STANDARD_DEVIATION 10.18 • n=5 Participants	41.6 years STANDARD_DEVIATION 10.44 • n=7 Participants	39.3 years STANDARD_DEVIATION 10.36 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized HAN	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Weight	68.29 kg STANDARD_DEVIATION 11.462 • n=5 Participants	64.25 kg STANDARD_DEVIATION 9.536 • n=7 Participants	66.27 kg STANDARD_DEVIATION 10.516 • n=5 Participants
Height	169.3 cm STANDARD_DEVIATION 8.11 • n=5 Participants	167.9 cm STANDARD_DEVIATION 5.70 • n=7 Participants	168.6 cm STANDARD_DEVIATION 6.89 • n=5 Participants
BMI	23.72 kg/m2 STANDARD_DEVIATION 2.888 • n=5 Participants	22.76 kg/m2 STANDARD_DEVIATION 2.974 • n=7 Participants	23.24 kg/m2 STANDARD_DEVIATION 2.908 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	11.617 ng/ml Interval 8.5821 to 14.6519	10.564 ng/ml Interval 8.3103 to 12.8177

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	123.5608 ng*h/ml Interval 93.4687 to 153.6529	124.0294 ng*h/ml Interval 98.1652 to 149.8936

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State	125.7605 ng*h/ml Interval 94.4572 to 157.0638	127.4811 ng*h/ml Interval 100.0286 to 154.9336

SECONDARY outcome

Timeframe: up to 35 days

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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State Number of AEs	17 AEs	13 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 Number of TEAEs	17 AEs	13 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 Number of related TEAEs	8 AEs	6 AEs

SECONDARY outcome

Timeframe: up to 35 days

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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Number of AEs Related to Vital Signs	7 AEs of vital signs related	5 AEs of vital signs related

SECONDARY outcome

Timeframe: up to 35 days

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

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Number of AEs Related to ECGs	0 AEs related to ECGs	0 AEs related to ECGs

SECONDARY outcome

Timeframe: up to 35 days

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.

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Number of Lab Tests With Clinical Significance	6 lab tests with clinical significance	3 lab tests with clinical significance

SECONDARY outcome

Timeframe: up to 35 days

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

Outcome measures

Outcome measures
Measure	Cmax of OTR 10 mg n=23 Participants the treatment group with OTR 10 mg	Cmax of OXYCONTIN 10 mg n=23 Participants the treatment group with OXYCONTIN 10 mg
Number of AEs Related to Physical Examination	0 AEs related to physical examinations	0 AEs related to physical examinations

Adverse Events

OTR 10 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

OXYCONTIN 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OTR 10 mg n=23 participants at risk the treatment group with OTR 10 mg	OXYCONTIN 10 mg n=23 participants at risk the treatment group with OXYCONTIN 10 mg
Cardiac disorders Heart rate decreased	17.4% 4/23 • Number of events 4 • 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. same with clinicaltrials.gov Definitions.	0.00% 0/23 • 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. same with clinicaltrials.gov Definitions.
Renal and urinary disorders WBC urine positive	13.0% 3/23 • Number of events 3 • 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. same with clinicaltrials.gov Definitions.	0.00% 0/23 • 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. same with clinicaltrials.gov Definitions.

Additional Information

Rongna. A

Mundipharma(China) Pharmaceutical. Co. Ltd

Phone: 86 10 65636885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place