CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release +3 moredrug
Likely dose
Dexmethylphenidate 5 Mg Oral Capsule, Extended Releasefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04138498
NCT04138498Phase 2Completed
CompareCT.gov

A Randomized, Single-dose, Four-sequence, Four-period, Crossover Study in Adult ADHD Subjects to Establish Safety, Tolerability, and Comparative Bioavailability of CTx-1301 (Dexmethylphenidate) to Focalin XR™ Under Fasted Conditions

Cingulate Therapeutics·interventional·Posted Oct 24, 2019·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet, and 2 other interventions for ADHD. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 24, 2019
Enrollment StartDec 6, 2019
Primary CompletionMar 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.7 years ago

Interventions

Dexmethylphenidate 5 Mg Oral Capsule, Extended Releasedrug

Reference listed drug (RLD) for comparative BA evaluation

Dexmethylphenidate 6.25 mg Tabletdrug

Experimental drug for comparative BA evaluation

Dexmethylphenidate 40 Mg Oral Capsule, Extended Releasedrug

Reference listed drug (RLD) for comparative BA evaluation

Dexmethylphenidate 50 mg Tabletdrug

Experimental drug for comparative BA evaluation