CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Tesomet "High dose" in fasted condition +3 moredrug
Likely dose
Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.from record
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Search/NCT03286829
NCT03286829Phase 1Completed
CompareCT.gov

A Randomized, Open-label, Single-dose, Parallel-arm, Phase 1 Study to Investigate the Pharmacokinetic Profile of a Fixed-Dose Combination Tablet of Tesofensine and Metoprolol (Tesomet) and Co-Administration of Tesofensine Plus Commercial Metoprolol in Adult Healthy Subjects

Saniona·interventional·Posted Sep 19, 2017·Updated May 14, 2020

In Brief

A Phase 1 clinical trial evaluating Tesomet "High dose" in fasted condition, Tesomet "Low dose" in fasted condition, and 2 other interventions for Healthy Male Subjects. Completed, enrolled 60 participants across 1 site.

Detailed Summary

A randomized, open-label, single-dose, parallel-arm, Phase 1 study to investigate the pharmacokinetic profile of a fixed-dose combination tablet of tesofensine and metoprolol (Tesomet) and co-administration of tesofensine plus commercial metoprolol in adult healthy subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Male Subjects
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 19, 2017
Enrollment StartDec 18, 2017
Primary CompletionFeb 6, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.8 years ago

Interventions

Tesomet "High dose" in fasted conditiondrug

To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.

Tesomet "Low dose" in fasted conditiondrug

To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.

Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.drug

To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.

Tesomet "High dose" in fed conditiondrug

To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.