Trial · NCT01654601
A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
NCT01654601, Phase 1, Completed, Dong Wha Pharmaceutical Co. Ltd.; results first posted 2014-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg. Trials, record NCT01654601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01654601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
- NCT number
- NCT01654601
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Conditions
- Schizophrenia
- Interventions
- DWCZP, Clozaril
- First posted
- 2012-08-01
- Last updated
- 2017-03-27
- Results first posted
- 2014-03-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Concentration of Clozapine in Plasma | Up to 12hours | |
| Secondary | Time to Reach Maximum Concentration of Clozapine in Plasma | Up to 12hours | |
| Secondary | Terminal Half Life of Clozapine in Plasma | Up to 12hours | |
| Secondary | Accumulation Rate of Clozapine in Plasma | Up tp 12hours |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Concentration of Clozapine in Plasma | Up to 12hours | ng/mL | MEAN | |
| SECONDARY | Time to Reach Maximum Concentration of Clozapine in Plasma | Up to 12hours | hour | MEAN | |
| SECONDARY | Terminal Half Life of Clozapine in Plasma | Up to 12hours | hour | MEAN | |
| SECONDARY | Accumulation Rate of Clozapine in Plasma | Up tp 12hours | ng/ml/hr | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Concentration of Clozapine in Plasma | A Group | 524.62 | Standard Deviation 272.51 | ng/mL | |
| Maximum Concentration of Clozapine in Plasma | B Group | 551.18 | Standard Deviation 263.26 | ng/mL | |
| Time to Reach Maximum Concentration of Clozapine in Plasma | A Group | 2.43 | Standard Deviation 1.71 | hour | |
| Time to Reach Maximum Concentration of Clozapine in Plasma | B Group | 2.75 | Standard Deviation 1.93 | hour | |
| Terminal Half Life of Clozapine in Plasma | A Group | 11.98 | Standard Deviation 6.89 | hour | |
| Terminal Half Life of Clozapine in Plasma | B Group | 10.88 | Standard Deviation 3.81 | hour | |
| Accumulation Rate of Clozapine in Plasma | A Group | 2.01 | Standard Deviation 0.81 | ng/ml/hr | |
| Accumulation Rate of Clozapine in Plasma | B Group | 1.88 | Standard Deviation 0.44 | ng/ml/hr |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Administration | STARTED | A Group | 14 | |
| 1st Administration | STARTED | B Group | 14 | |
| 1st Administration | COMPLETED | A Group | 12 | |
| 1st Administration | COMPLETED | B Group | 12 | |
| 1st Administration | NOT COMPLETED | A Group | 2 | |
| 1st Administration | NOT COMPLETED | B Group | 2 | |
| 2nd Administration | STARTED | A Group | 12 | |
| 2nd Administration | STARTED | B Group | 12 | |
| 2nd Administration | COMPLETED | A Group | 11 | |
| 2nd Administration | COMPLETED | B Group | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | A Group | 1 | 14 | |
| other | Nausea | Gastrointestinal disorders | B Group | 0 | 14 | |
| other | Dyspepsia | Gastrointestinal disorders | A Group | 2 | 14 | |
| other | Dyspepsia | Gastrointestinal disorders | B Group | 1 | 14 | |
| other | Pharyngotonsillitis | Infections and infestations | A Group | 0 | 14 | |
| other | Pharyngotonsillitis | Infections and infestations | B Group | 1 | 14 | |
| other | Nasopharyngitis | Infections and infestations | A Group | 0 | 14 | |
| other | Nasopharyngitis | Infections and infestations | B Group | 1 | 14 | |
| other | Headache | Nervous system disorders | A Group | 0 | 14 | |
| other | Headache | Nervous system disorders | B Group | 1 | 14 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A Group | ||
| Total, all-cause mortality | B Group | ||
| Total, other adverse events | A Group | 5 | 14 |
| Total, other adverse events | B Group | 4 | 14 |
| Total, serious adverse events | A Group | 1 | 14 |
| Total, serious adverse events | B Group | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| A Group vs B Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01654601
GET https://conductscience.org/api/trials/v1/NCT01654601/events?page=2