Trial · NCT03398330
OTR Tablet 40 mg Fed-state Bioequivalence Study
NCT03398330, Phase 1, Completed, Mundipharma (China) Pharmaceutical Co. Ltd; results first posted 2019-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. OTR Tablet 40 mg Fed-state Bioequivalence Study. Trials, record NCT03398330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03398330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OTR Tablet 40 mg Fed-state Bioequivalence Study
- NCT number
- NCT03398330
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Conditions
- Chronic Pain
- Interventions
- Oxycodone Tamper Resistant, OxyContin®
- First posted
- 2018-01-12
- Last updated
- 2019-11-15
- Results first posted
- 2019-11-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | 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. |
| Primary | AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | 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. |
| Primary | AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | 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. |
| Secondary | Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | 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 40 mg and OXYCONTIN® tablet 40 mg. |
| Secondary | Number of Lab Tests With Clinical Significance | up to 35 days | 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). |
| Secondary | Number of AEs Related to Vital Signs | up to 35 days | 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). |
| Secondary | Number of AEs Related to ECGs | up to 35 days | Summarized table of 12-lead ECG is presented. ECG was measured at Screening and 4 days after IMP dosing in Period 2. |
| Secondary | Number of AEs Related to Physical Examination | up to 35 days | Physical examination were measured at Screening, 1 day before IMP dosing and 4 days after IMP dosing in each period. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | up to 32 hours | ng/ml | MEAN | |
| PRIMARY | AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | up to 32 hours | ng*h/ml | MEAN | |
| PRIMARY | AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | up to 32 hours | ng*h/ml | MEAN | |
| SECONDARY | Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | up to 35 days | TEAEs | NUMBER | |
| SECONDARY | Number of Lab Tests With Clinical Significance | up to 35 days | Lab tests with clinical significance | NUMBER | |
| SECONDARY | Number of AEs Related to Vital Signs | up to 35 days | AEs of vital signs related | NUMBER | |
| SECONDARY | Number of AEs Related to ECGs | up to 35 days | AEs of ECG related | NUMBER | |
| SECONDARY | Number of AEs Related to Physical Examination | up to 35 days | AEs related to Physical examination | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | Cmax of OTR Tablet 40 mg | 86.15 | 90% Confidence Interval 67.895 to 104.405 | ng/ml | |
| Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | Cmax of OXYCONTIN Tablet 40 mg | 63.54 | 90% Confidence Interval 50.035 to 77.045 | ng/ml | |
| AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | AUCt of OTR Tablet 40 mg | 641.3017 | 90% Confidence Interval 517.97802 to 764.62538 | ng*h/ml | |
| AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | AUCt of OXYCONTIN Tablet 40 mg | 646.2133 | 90% Confidence Interval 514.12207 to 778.30453 | ng*h/ml | |
| AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | AUCINF of OTR Tablet 40 mg | 648.2546 | 90% Confidence Interval 521.43808 to 775.07112 | ng*h/ml | |
| AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State | AUCINF of OXYCONTIN Tablet 40 mg | 664.0493 | 90% Confidence Interval 521.26837 to 806.8302 | ng*h/ml | |
| Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | Adverse Events of OTR Tablet 40 mg | Number of AEs (#) | 29 | TEAEs | |
| Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | Adverse Events of OXYCONTIN Tablet 40 mg | Number of AEs (#) | 37 | TEAEs | |
| Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | Adverse Events of OTR Tablet 40 mg | Number of TEAEs (#) | 29 | TEAEs | |
| Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State | Adverse Events of OXYCONTIN Tablet 40 mg | Number of TEAEs (#) | 35 | TEAEs |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | OTR 40 Mg-OXYCONTIN 40 mg | 21 | |
| Period 1 | STARTED | OXYCONTIN 40 Mg-OTR 40 mg | 21 | |
| Period 1 | COMPLETED | OTR 40 Mg-OXYCONTIN 40 mg | 20 | |
| Period 1 | COMPLETED | OXYCONTIN 40 Mg-OTR 40 mg | 17 | |
| Period 1 | NOT COMPLETED | OTR 40 Mg-OXYCONTIN 40 mg | 1 | |
| Period 1 | NOT COMPLETED | OXYCONTIN 40 Mg-OTR 40 mg | 4 | |
| Period 2 | STARTED | OTR 40 Mg-OXYCONTIN 40 mg | 20 | |
| Period 2 | STARTED | OXYCONTIN 40 Mg-OTR 40 mg | 17 | |
| Period 2 | COMPLETED | OTR 40 Mg-OXYCONTIN 40 mg | 19 | |
| Period 2 | COMPLETED | OXYCONTIN 40 Mg-OTR 40 mg | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | OTR 40mg | 4 | 37 | 4 |
| other | Nausea | Gastrointestinal disorders | OXYCONTIN® 40mg | 4 | 40 | 4 |
| other | Vomit | Gastrointestinal disorders | OTR 40mg | 0 | 37 | 0 |
| other | Vomit | Gastrointestinal disorders | OXYCONTIN® 40mg | 4 | 40 | 8 |
| other | Blood triglycerides increased | Endocrine disorders | OTR 40mg | 1 | 37 | 1 |
| other | Blood triglycerides increased | Endocrine disorders | OXYCONTIN® 40mg | 5 | 40 | 5 |
| serious | Drug-induced liver injury | Injury, poisoning and procedural complications | OTR 40mg | 1 | 37 | 1 |
| serious | Drug-induced liver injury | Injury, poisoning and procedural complications | OXYCONTIN® 40mg | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTR 40mg | 0 | 37 |
| Total, all-cause mortality | OXYCONTIN® 40mg | 0 | 40 |
| Total, other adverse events | OTR 40mg | 5 | 37 |
| Total, other adverse events | OXYCONTIN® 40mg | 10 | 40 |
| Total, serious adverse events | OTR 40mg | 1 | 37 |
| Total, serious adverse events | OXYCONTIN® 40mg | 0 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OTR 40mg vs OXYCONTIN® 40mg: deaths from any cause | Trial comparisons |
| OTR 40mg vs OXYCONTIN® 40mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03398330
GET https://conductscience.org/api/trials/v1/NCT03398330/registered