Trial · NCT01021020
Bioequivalence Study of Colchicine Tablets
NCT01021020, Phase 1, Completed, Mutual Pharmaceutical Company, Inc.; results first posted 2009-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study of Colchicine Tablets. Trials, record NCT01021020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021020
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study of Colchicine Tablets
- NCT number
- NCT01021020
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Conditions
- Healthy
- Interventions
- Colchicine, Colchicine, Colchicine/Probenecid
- First posted
- 2009-11-26
- Last updated
- 2009-12-09
- Results first posted
- 2009-11-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Plasma Concentration (Cmax) | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | The maximum or peak concentration that colchicine reaches in the plasma. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Plasma Concentration (Cmax) | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | pg/mL | MEAN | |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | pg-hr/mL | MEAN | |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | Colchicine(fasted)-could not be determined for Subject 25. Colchicine(high-fat meal)-could not be determined for Subjects 22,25, and 28. Colchicine/Probenecid(fasted)-could not be determined for Subject 25. | pg-hr/mL | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Plasma Concentration (Cmax) | Colchicine 0.6 mg (Fasted) | 2,503.04 | Standard Deviation 722.05 | pg/mL | |
| Maximal Plasma Concentration (Cmax) | Colchicine (High-fat Meal) | 2,496.88 | Standard Deviation 695.09 | pg/mL | |
| Maximal Plasma Concentration (Cmax) | Colchicine 0.5 mg/ Probenecid 500 mg (Fasted) | 1,706.03 | Standard Deviation 560.73 | pg/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Colchicine 0.6 mg (Fasting) | 12,588.61 | Standard Deviation 6,120.73 | pg-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Colchicine 0.6 mg (High-fat Meal) | 10,490.95 | Standard Deviation 4,025.80 | pg-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Colchicine 0.5 mg/ Probenecid 500 mg (Fasting) | 8,090.05 | Standard Deviation 6,111.99 | pg-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Colchicine 0.6 mg (Fasted) | 14,112.52 | Standard Deviation 5,595.40 | pg-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Colchicine 0.6 mg (High-fat Meal) | 11,404.09 | Standard Deviation 2,895.68 | pg-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Colchicine 0.5 mg/ Probenecid 500 mg (Fasted) | 8,481.41 | Standard Deviation 2,829.75 | pg-hr/mL |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I | STARTED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 28 | |
| Period I | COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 26 | |
| Period I | NOT COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 2 | |
| 14 Day Washout Period A | STARTED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 26 | |
| 14 Day Washout Period A | COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 25 | |
| 14 Day Washout Period A | NOT COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 1 | |
| Period II | STARTED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 25 | |
| Period II | COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 25 | |
| Period II | NOT COMPLETED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 0 | |
| 14 Day Washout Period B | STARTED | Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events33
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 | Colchicine 0.6 mg (Fasted) | 0 | 26 | 0 |
| other | nausea | Gastrointestinal disorders | Colchicine 0.6 mg (Fed) | 0 | 27 | 0 |
| other | nausea | Gastrointestinal disorders | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | 2 | 27 | 2 |
| other | stomach discomfort | Gastrointestinal disorders | Colchicine 0.6 mg (Fasted) | 0 | 26 | 0 |
| other | stomach discomfort | Gastrointestinal disorders | Colchicine 0.6 mg (Fed) | 1 | 27 | 1 |
| other | stomach discomfort | Gastrointestinal disorders | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | 0 | 27 | 0 |
| other | vomiting | Gastrointestinal disorders | Colchicine 0.6 mg (Fasted) | 0 | 26 | 0 |
| other | vomiting | Gastrointestinal disorders | Colchicine 0.6 mg (Fed) | 1 | 27 | 1 |
| other | vomiting | Gastrointestinal disorders | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | 0 | 27 | 0 |
| other | paresthesia | Musculoskeletal and connective tissue disorders | Colchicine 0.6 mg (Fasted) | 1 | 26 | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colchicine 0.6 mg (Fasted) | ||
| Total, all-cause mortality | Colchicine 0.6 mg (Fed) | ||
| Total, all-cause mortality | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | ||
| Total, other adverse events | Colchicine 0.6 mg (Fasted) | 5 | 26 |
| Total, other adverse events | Colchicine 0.6 mg (Fed) | 3 | 27 |
| Total, other adverse events | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | 4 | 27 |
| Total, serious adverse events | Colchicine 0.6 mg (Fasted) | 0 | 26 |
| Total, serious adverse events | Colchicine 0.6 mg (Fed) | 0 | 27 |
| Total, serious adverse events | Colchicine 0.5 mg/Probenecid 500 mg (Fasted) | 0 | 27 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01021020
GET https://conductscience.org/api/trials/v1/NCT01021020/events?page=2