Phase 1
N=26
A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01121900 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Bioequivalence Based Cmax — 1230.7; 2947.7 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Trazodone HCl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Labopharm Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence Based Cmax |
1230.7; 2947.7 | — |
| PRIMARY Bioequivalence Based on AUC(0-tlast) |
28138.4; 34272.4 | — |
| PRIMARY Bioequivalence Based on AUC(0-∞) |
29672.5; 35258.5 | — |
| SECONDARY Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)] |
18331.0; 24602.2 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
9.00; 8.33 | — |
| SECONDARY Apparent Terminal Elimination Rate Constant (λz) |
0.064; 0.090 | — |
| SECONDARY Apparent Terminal Half-life (t½.z) |
11.8; 8.3 | — |
Summary
The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.
Eligibility Criteria
Inclusion Criteria
- Healthy male and female subjects 18 to 10 drinks weekly), or regular exposure to other substances of abuse.
- Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not have affected the outcome of the study in the opinion of the investigator. Hormonal contraceptive agents were not allowed.
- Participation in another study with an experimental drug, where the last administration (of previous study medication) was within 8 weeks before the first administration of study medication.
- Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity to the study medication or any related medication.
- History of bronchial asthma.
- History of epilepsy.
- History of porphyria.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to have influenced the study outcome.
- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of study medication.
- Diagnosis of hypotension made during the screening period.
- Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
- Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
- Positive testing for HIV and/or Hepatitis B and/or Hepatitis C.
- Positive urine screen for drugs of abuse.
- Positive urine screen for tobacco use.
- A serum pregnancy test (beta human chorionic gonadotropin [β-HCG]) either positive or not performed or lactation.
Data sourced from ClinicalTrials.gov (NCT01121900). 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.