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CTx-1301 Comparative Bioavailability Study

NCT04138498 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-04-08

Study results available
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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.

Conditions

  • ADHD

Interventions

DRUG

Dexmethylphenidate 5 Mg Oral Capsule, Extended Release

Reference listed drug (RLD) for comparative BA evaluation

DRUG

Dexmethylphenidate 6.25 mg Tablet

Experimental drug for comparative BA evaluation

DRUG

Dexmethylphenidate 40 Mg Oral Capsule, Extended Release

Reference listed drug (RLD) for comparative BA evaluation

DRUG

Dexmethylphenidate 50 mg Tablet

Experimental drug for comparative BA evaluation

Sponsors & Collaborators

  • Cingulate Therapeutics

    lead INDUSTRY

Principal Investigators

  • Matt Brams, MD · Sponsor Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2020-03-06
Completion
2020-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138498 on ClinicalTrials.gov