CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
PDC-1421 Capsule +1 moredrug
Likely dose
Not stated in 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/NCT05202327
NCT05202327Phase 2Completed
CompareCT.gov

A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II

BioLite, Inc.·interventional·Posted Jan 21, 2022·Updated May 6, 2026

In Brief

A Phase 2 clinical trial evaluating PDC-1421 Capsule and Placebo for Attention-Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 99 participants across 6 sites in 2 countries.

Detailed Summary

Part II is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective of this trial is to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD. The secondary objective is to evaluate the safety of PDC-1421 Capsule in subjects receiving PDC-1421 at various dose levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit Hyperactivity Disorder (ADHD)
CountriesTaiwan, United States
CollaboratorsABVC BioPharma, Inc.

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 21, 2022
Enrollment StartApr 7, 2022
Primary CompletionDec 6, 2023
Study CompletionApr 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.4 years ago

Interventions

PDC-1421 Capsuledrug

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as the active ingredient.

Placebodrug

The placebo contained corn starch.