NCT01654601 (DWCZP-I-1) is a Phase 1 clinical trial of DWCZP in Schizophrenia, sponsored by Dong Wha Pharmaceutical Co. Ltd..

Who is sponsoring NCT01654601?

NCT01654601 is sponsored by Dong Wha Pharmaceutical Co. Ltd..

What drugs are being tested in NCT01654601?

Interventions in NCT01654601: DWCZP, Clozaril.

What condition does NCT01654601 study?

NCT01654601 studies Schizophrenia.

Is NCT01654601 still recruiting?

NCT01654601 is currently completed. Last updated 22 February 2017.

Are results published for NCT01654601?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-02-22 · How we verify

NCT01654601: DWCZP-I-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trials to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg After a Multi-dose Oral Administration in Schizophrenia Patients

Completed Phase 1 Results posted Last updated 22 February 2017

What this trial tests

Phase 1 trial testing DWCZP in Schizophrenia in 28 participants. Completed in 1 August 2013.

Timeline

1 June 2012

Primary endpoint
1 April 2013

1 August 2013

Quick facts

Lead sponsor	Dong Wha Pharmaceutical Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	28
Start date	1 June 2012
Primary completion	1 April 2013
Estimated completion	1 August 2013
Sites	5 locations across South Korea

Drugs / interventions tested

DWCZP — full drug profile →
Clozaril — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Dong Wha Pharmaceutical Co. Ltd. — full company profile →

Who can join

Adults 20 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum Concentration of Clozapine in Plasma
Time frame: Up to 12hours

Sponsor's own description

To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Dong Wha Pharmaceutical Co. Ltd. trials

Trials by the same sponsor.

NCT06875193 — DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes · Phase 4 · recruiting
NCT05823870 — This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 · Phase 1 · completed
NCT05874180 — A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers in Fed Condition · Phase 1 · completed
NCT05874167 — A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers · Phase 1 · completed
NCT05403281 — A Pharmacokinetic Study of DW6012 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01654601 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dong Wha Pharmaceutical Co. Ltd.
Last refreshed: 22 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01654601.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing