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)
This study has been completed.
Information provided by (Responsible Party):
First received: May 10, 2010
Last updated: April 24, 2012
Last verified: April 2012
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.
Drug: Trazodone HCl
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered as a Single Dose) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) Under Fasting Conditions
Primary Outcome Measures:
Secondary Outcome Measures:
- Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)] [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 68 hours ] [ Designated as safety issue: No ]
- Apparent Terminal Elimination Rate Constant (λz) [ Time Frame: 68 hours ] [ Designated as safety issue: No ]
The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.
- Apparent Terminal Half-life (t½.z) [ Time Frame: 68 hours ] [ Designated as safety issue: No ]
The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2008 (Final data collection date for primary outcome measure)
Experimental: Trazodone HCl OAD
OAD: Once A Day
Drug: Trazodone HCl
Dosage form: Extended-release caplets containing 300 mg trazodone HCl
Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours.
Other Name: Oleptro
Active Comparator: Trazodone HCl (Apotex Corp.)
Drug: Trazodone HCl
Dosage form: Immediate-release tablets containing 100 mg trazodone HCl
Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.
|Ages Eligible for Study:
||18 Years to 55 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to have limited the validity of consent to participate in the study or to have limited the ability to comply with protocol requirements.
- History of, or current compulsive alcohol abuse (> 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.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 10, 2010
|Results First Received:
||June 22, 2010
||April 24, 2012
||South Africa: Medicines Control Council
Keywords provided by Labopharm Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 27, 2016
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation