Phase 1
Completed N=24
Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers
Healthy
Source: ClinicalTrials.gov NCT00839072 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Bioequivalence Based on Cmax — 1060.8; 1743.3 ng/mL
Summary
The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence Based on Cmax |
1060.8; 1743.3 | — |
| PRIMARY Bioequivalence Based on AUCT |
29180.6; 36002.4 | — |
| PRIMARY Bioequivalence Based on AUC∞ |
30913.7; 37273.4 | — |
| SECONDARY Time of Maximum Measured Plasma Concentration (Tmax) |
6.00; 9.50 | — |
| SECONDARY Apparent Terminal Elimination Half-Life [T½el] |
14.37; 12.16 | — |
| SECONDARY Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24] |
16885.8; 22512.8 | — |
Eligibility Criteria
Inclusion Criteria
- Availability for entire study period and willingness to adhere to protocol requirements as evidenced by signed informed consent
- Male or female volunteer, aged between 18 and 45 years inclusively
- BMI ≥20 and 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, and rifampin), in the previous 28 days before day 1 of this study
- Females who are pregnant according to a positive serum pregnancy test, or are lactating
- Females of childbearing potential who refuse to use an acceptable method of contraception from the screening visit and throughout the study
- Volunteers who took an investigational product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc) in the previous 56 days before day 1 of the study
- Positive urine screening for drugs of abuse
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive results to HIV, HBsAg, or anti-HCV tests
Data sourced from ClinicalTrials.gov (NCT00839072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.