Trial · NCT04819438
Riluzole Orodispersible Film Replicate Bioavailability
NCT04819438, Phase 1, Completed, Cross Research S.A.; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Riluzole Orodispersible Film Replicate Bioavailability. Trials, record NCT04819438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04819438
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Riluzole Orodispersible Film Replicate Bioavailability
- NCT number
- NCT04819438
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Cross Research S.A.
- Conditions
- Healthy Participants
- Interventions
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- First posted
- 2021-03-29
- Last updated
- 2025-05-02
- Results first posted
- 2025-05-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the Bioequivalent Rate of Absorption (Cmax) of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose) and 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after the drug administration | For each individual, the maximum plasma concentration (Cmax) of riluzole after replicate single dose administration of Test and Reference was measured. The Cmax 90% confidence interval of the ratio Test/Reference of the population means was calculated. The bioequivalence is demonstrated when the 90% confidence Interval of this ratio lies within the range 80.00-125.00% (acceptance interval). |
| Primary | Evaluation of the Bioequivalent Extent of Absorption (AUC0-t) of Riluzole After Replicate Single Dose Administration of Test and Reference. | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | For each individual, the area under the concentration-time curve from single dose Test and Reference administration to the last observed concentration time t (AUC0-t) of riluzole was measured. The AUC0-t 90% confidence interval of the ratio Test/Reference of the population means was calculated. The bioequivalence is demonstrated when the 90% confidence Interval of this ratio lies within the range 80.00-125.00% (acceptance interval). |
| Secondary | To Describe the t1/2 (Half-life) of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | To Describe the half-life of riluzole, calculated, if feasible, as ln2/λz, After Replicate Single Dose Administration of Test and Reference. |
| Secondary | To Describe the AUC0-∞ of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | For each individual, the area under the concentration-time curve extrapolated to infinity after single dose administration of Test and Reference (AUC0-∞) was measured. The AUC0-∞ 90% confidence interval of the ratio Test/Reference of the population means was calculated. The bioequivalence is demonstrated when the 90% confidence Interval of this ratio lies within the range 80.00-125.00% (acceptance interval). |
| Secondary | Description Tmax: Time to Achieve Cmax Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | The results will be displayed and summarised in tables and figures. |
| Secondary | Evaluation of the Test Product Palatability | Immediately after 1st Test product administration, approximately within 5 minutes after administration | Palatability was scored according to the following scale. Palatability evaluation description and scores (between brackets): Very unpleasant (0), Unpleasant (1), Acceptable (2), Good (3), Very good (4). Minimun value is 0, maximum value is 4. An higher score mean a better outcome. |
| Secondary | Evaluation of the Test Product Palatability | Immediately after 2nd Test product administration, approximately within 5 minutes after administration | Palatability was scored according to the following scale. Palatability evaluation description and scores (between brackets): Very unpleasant (0), Unpleasant (1), Acceptable (2), Good (3), Very good (4). Minimun value is 0, maximum value is 4. An higher score mean a better outcome. |
| Secondary | Number of Participants With Mucosal Irritation | pre-dose (0), 0.5 and 1 h after the drug administration | Mouth inspections were performed before the Test administration and 30 min and 1 h after administrations of Test, to check the mucosal irritation at the application site. The outcome number shows the overall number of subjects with mucosal irritation. |
| Secondary | Haematology, Blood Chemistry and Urinalysis Laboratory Tests Interpretation | At screening (initial visit) and at final visit (approximately 1 month) | Overall investigator's interpretation (as normal or abnormal and, if abnormal, clinically significant or not clinically significant). The following analyses were performed at screening: Leukocytes, erythrocytes, haemoglobin, haematocrit, MCV, MCH, MCHC, thrombocytes, electrolytes, enzymes (alkaline phosphatase, γ-GT, AST, ALT), total bilirubin, creatinine, glucose, urea, uric acid, total cholesterol, triglycerides, cotinine, total proteins. Serum pregnancy test (women). Urine analysis: pH, specific weight, appearance, colour, nitrites, proteins, glucose, urobilinogen, bilirubin, ketones, haematic pigments, leukocytes. Urine sediment (analysis performed only if positive): leukocytes, erythrocytes, flat cells, round cells, crystals, cylinders, mucus, bacteria. Hepatitis B (HBs antigen), Hepatitis C (HCV antibodies), HIV 1/2 (HIV Ag/Ab combo). The same analyses, with the exception of cotinine, urine drug test, virology and pregnancy test, were performed at the final visit |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of the Bioequivalent Rate of Absorption (Cmax) of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose) and 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after the drug administration | ng/mL | MEAN | |
| PRIMARY | Evaluation of the Bioequivalent Extent of Absorption (AUC0-t) of Riluzole After Replicate Single Dose Administration of Test and Reference. | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | h*ng/mL | MEAN | |
| SECONDARY | To Describe the t1/2 (Half-life) of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | h | MEAN | |
| SECONDARY | To Describe the AUC0-∞ of Riluzole After Replicate Single Dose Administration of Test and Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | h*ng/mL | MEAN | |
| SECONDARY | Description Tmax: Time to Achieve Cmax Reference | 0 h (pre-dose), 15, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 h after drug administration | h | MEDIAN | |
| SECONDARY | Evaluation of the Test Product Palatability | Immediately after 1st Test product administration, approximately within 5 minutes after administration | Data for this outcome measure were only collected after administration of the Test product (Riluzole orodispersible film). The overall number of participants analyzed is the number of subjects who received Riluzole 50 mg orodispersible film (T) at the 1st administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of the Test Product Palatability | Immediately after 2nd Test product administration, approximately within 5 minutes after administration | Data for this outcome measure were only collected after administration of the Test product (Riluzole orodispersible film). The overall number of participants analyzed is the number of subjects who received Riluzole 50 mg orodispersible film (T) at the 2nd administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Mucosal Irritation | pre-dose (0), 0.5 and 1 h after the drug administration | Data for this outcome measure were only collected for the Test product (Riluzole orodispersible film). No mouth inspection was performed after Reference (Rilutek®) administration. The overall number of participants analyzed is the number of subjects who received Riluzole 50 mg orodispersible film (T). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Haematology, Blood Chemistry and Urinalysis Laboratory Tests Interpretation | At screening (initial visit) and at final visit (approximately 1 month) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of the Bioequivalent Rate of Absorption (Cmax) of Riluzole After Replicate Single Dose Administration of Test and Reference | Riluzole Orodispersible Film (Test) | 315.62 | Standard Deviation 124.95 | ng/mL | |
| Evaluation of the Bioequivalent Rate of Absorption (Cmax) of Riluzole After Replicate Single Dose Administration of Test and Reference | Rilutek® Tablet (Reference) | 278.81 | Standard Deviation 123.32 | ng/mL | |
| Evaluation of the Bioequivalent Extent of Absorption (AUC0-t) of Riluzole After Replicate Single Dose Administration of Test and Reference. | Riluzole Orodispersible Film (Test) | 1263.40 | Standard Deviation 571.58 | h*ng/mL | |
| Evaluation of the Bioequivalent Extent of Absorption (AUC0-t) of Riluzole After Replicate Single Dose Administration of Test and Reference. | Rilutek® Tablet (Reference) | 1135.98 | Standard Deviation 514.98 | h*ng/mL | |
| To Describe the t1/2 (Half-life) of Riluzole After Replicate Single Dose Administration of Test and Reference | Riluzole Orodispersible Film (Test) | 10.22 | Standard Deviation 1.66 | h | |
| To Describe the t1/2 (Half-life) of Riluzole After Replicate Single Dose Administration of Test and Reference | Rilutek® Tablet (Reference) | 10.22 | Standard Deviation 1.48 | h | |
| To Describe the AUC0-∞ of Riluzole After Replicate Single Dose Administration of Test and Reference | Riluzole Orodispersible Film (Test) | 1348.31 | Standard Deviation 630.80 | h*ng/mL | |
| To Describe the AUC0-∞ of Riluzole After Replicate Single Dose Administration of Test and Reference | Rilutek® Tablet (Reference) | 1207.79 | Standard Deviation 566.13 | h*ng/mL | |
| Description Tmax: Time to Achieve Cmax Reference | Riluzole Orodispersible Film (Test) | 0.75 | Full Range 0.25 to 2 | h | |
| Description Tmax: Time to Achieve Cmax Reference | Rilutek® Tablet (Reference) | 0.75 | Full Range 0.25 to 4 | h |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) | 27 | |
| Overall Study | STARTED | Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) | 27 | |
| Overall Study | COMPLETED | Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) | 26 | |
| Overall Study | COMPLETED | Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) | 25 | |
| Overall Study | NOT COMPLETED | Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) | 1 | |
| Overall Study | NOT COMPLETED | Rilutek 50mg (Reference) / Riluzole 50mg (Test) / Rilutek 50mg (Reference) / Riluzole 50mg (Test) | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | Hypoaesthesia oral | Gastrointestinal disorders | Riluzole Orodispersible Film (Test) | 52 | 52 | 102 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Rilutek® (Reference) | 0 | 53 | 0 |
| other | Headache | Nervous system disorders | Riluzole Orodispersible Film (Test) | 11 | 52 | 15 |
| other | Headache | Nervous system disorders | Rilutek® (Reference) | 14 | 53 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riluzole Orodispersible Film (Test) | 0 | 52 |
| Total, all-cause mortality | Rilutek® (Reference) | 0 | 53 |
| Total, other adverse events | Riluzole Orodispersible Film (Test) | 52 | 52 |
| Total, other adverse events | Rilutek® (Reference) | 14 | 53 |
| Total, serious adverse events | Riluzole Orodispersible Film (Test) | 0 | 52 |
| Total, serious adverse events | Rilutek® (Reference) | 0 | 53 |
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 |
|---|---|
| Riluzole Orodispersible Film (Test) vs Rilutek® (Reference): deaths from any cause | Trial comparisons |
| Riluzole Orodispersible Film (Test) vs Rilutek® (Reference): 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.
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