Phase 1
N=30
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
Healthy Subjects · Bioavailability · Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT01121926 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Bioequivalence Based on Cmax,ss — 1812.026; 3117.778 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
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence Based on Cmax,ss |
1812.026; 3117.778 | — |
| PRIMARY Bioequivalence Based on AUCss |
29131.374; 33058.024 | — |
| SECONDARY Minimum Plasma Concentration (Cmin,ss) |
673.889; 842.763 | — |
| SECONDARY Plasma Concentration at 24 Hours Post-evening Dose (C24h) |
747.270; 919.111 | — |
| SECONDARY Time to Peak Exposure (Tmax) |
8.00; 8.33 | — |
| SECONDARY Percentage Swing |
210.769; 302.805 | — |
| SECONDARY Percentage Peak-Trough Fluctuation (%PTF) |
97.090; 174.768 | — |
Summary
The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.
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 affect the outcome of the study in the opinion of the investigator.
- 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 with evidence to this effect.
- 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 influence 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 (NCT01121926). 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.