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drugset / Trial / NCT04138498

CTx-1301 Comparative Bioavailability Study

NCT04138498 ↗

Phase 1/2 Completed 45 enrolled Cingulate Therapeutics
RandomizedCrossoverTriple-blindTreatment

Summary

The primary purpose of this study is to compare the bioavailability of CTx-1301 (dexmethylphenidate) to the registered listed drug, Focalin XR and to evaluate dose proportionality of CTx-1301. In addition, this study seeks to characterize the pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.

Timeline

Start
2019-12-06
Primary completion
2020-03-06
Completion
2020-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject dexmethylphenidate Unknown 5 mg Oral
Subject dexmethylphenidate Unknown 6.25 mg Oral
Subject dexmethylphenidate Unknown 40 mg Oral
Subject dexmethylphenidate Unknown 50 mg Oral

Indications

attention deficit-hyperactivity disorder