A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State
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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Healthy Subjects Bioavailability Pharmacokinetics |
| Intervention: |
Drug: Trazodone HCl |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Test (Trazodone Contramid® OAD) First |
Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2. IR = Immediate Release. |
| Reference (Trazodone IR [Apotex Corp.]) First |
Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2. IR = Immediate Release. |
Participant Flow for 3 periods
Period 1: First Intervention Period
| Test (Trazodone Contramid® OAD) First | Reference (Trazodone IR [Apotex Corp.]) First | |
|---|---|---|
| STARTED | 15 | 15 |
| COMPLETED | 14 | 15 |
| NOT COMPLETED | 1 | 0 |
| Adverse Event | 1 | 0 |
Period 2: Washout Period
| Test (Trazodone Contramid® OAD) First | Reference (Trazodone IR [Apotex Corp.]) First | |
|---|---|---|
| STARTED | 14 | 15 |
| COMPLETED | 14 | 13 |
| NOT COMPLETED | 0 | 2 |
| Adverse Event | 0 | 1 |
| Positive pregnancy test | 0 | 1 |
Period 3: Second Intervention Period
| Test (Trazodone Contramid® OAD) First | Reference (Trazodone IR [Apotex Corp.]) First | |
|---|---|---|
| STARTED | 14 | 13 |
| COMPLETED | 14 | 13 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Entire Study Population |
Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first. IR = Immediate Release |
Baseline Measures
| Entire Study Population | |
|---|---|
|
Number of Participants
[units: participants] |
30 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
25.7 ± 8.4 |
|
Gender
[units: participants] |
|
| Female | 9 |
| Male | 21 |
|
Region of Enrollment
[units: participants] |
|
| South Africa | 30 |
Outcome Measures
| 1. Primary: | Bioequivalence Based on Cmax,ss [ Time Frame: 9 days ] |
| 2. Primary: | Bioequivalence Based on AUCss [ Time Frame: 9 days ] |
| 3. Secondary: | Minimum Plasma Concentration (Cmin,ss) [ Time Frame: 9 days ] |
| 4. Secondary: | Plasma Concentration at 24 Hours Post-evening Dose (C24h) [ Time Frame: 9 days ] |
| 5. Secondary: | Time to Peak Exposure (Tmax) [ Time Frame: 9 days ] |
| 6. Secondary: | Percentage Swing [ Time Frame: 9 days ] |
| 7. Secondary: | Percentage Peak-Trough Fluctuation (%PTF) [ Time Frame: 9 days ] |