Trial · NCT07763964
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study.
NCT07763964, Not applicable, Completed, ADIUM
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study. Trials, record NCT07763964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07763964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study.
- NCT number
- NCT07763964
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 46 participants, actual
- Lead sponsor
- ADIUM
- Conditions
- Bioequivalance
- Interventions
- Janumet XR, Sitagliptin/Metformin FDC
- First posted
- 2026-08-13
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bioequivalence based on the pharmacokinetic parameter: AUC0-t | Through 72 hours Post Dose | Bioequivalence based on the pharmacokinetic parameter: AUC0-t |
| Primary | Bioequivalence based on the pharmacokinetic parameter: Cmax | Through 72 Hours Post Dose | Bioequivalence based on the pharmacokinetic parameter: Cmax |
| Secondary | Characterize the pharmacokinetic parameter: AUC0-inf | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: AUC0-inf |
| Secondary | Characterize the pharmacokinetic parameter: time to maximum concentration (tmax) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: time to maximum concentration (tmax) |
| Secondary | Characterize the pharmacokinetic parameter: elimination constant (Ke) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: elimination constant (Ke) |
| Secondary | Characterize the pharmacokinetic parameter: half-life (t1/2) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: half-life (t1/2) |
| Secondary | Establish the frequency, severity, and seriousness of adverse events that occurred during the study. | Until the final visit (7 days after the last dose) | Establish the frequency, severity, and seriousness of adverse events that occurred during the study. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07763964
GET https://conductscience.org/api/trials/v1/NCT07763964/registered