Completed PHASE1 INTERVENTIONAL 2-arm NCT00685165

Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Primidone 50 mg, Compared to an Equivalent Dose of Primidone (Mysoline®) in Healthy Adult Subjects

Sponsor: Mutual Pharmaceutical Company, Inc.

Conditions Therapeutic Equivalency

Interventions Primidone (Mysoline®) 50 mg Tablet Primidone 50 mg Tablet

Updated 6 times since 2017 Last updated: Dec 16, 2009 Started: May 31, 2004 Primary completion: Jun 30, 2004 Completion: Jun 30, 2004

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Therapeutic Equivalency, this trial is completed. The trial is conducted by Mutual Pharmaceutical Company, Inc. and has accumulated 6 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

May 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mutual Pharmaceutical Company, Inc.

Data source: Mutual Pharmaceutical Company, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.