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
概览
- 阶段
- 1 期
- 干预措施
- Trazodone HCl
- 疾病 / 适应症
- Healthy
- 发起方
- Labopharm Inc.
- 入组人数
- 26
- 主要终点
- Bioequivalence Based Cmax
- 状态
- 已完成
- 最后更新
- 14年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •Healthy male and female subjects 18 to \< 56 years of age.
- •Body mass within 10% of the ideal mass in relation to height and age, according to Body Mass Index.
- •Body mass not less than 53 kg.
- •Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
- •Normal 12-lead electrocardiogram (ECG) and vital signs, or abnormalities, which the investigator did not consider a disqualification for participation in the study.
- •Willingness to undergo a pre- and post-study physical examination and laboratory investigations.
- •Ability to comprehend and willingness to sign both statements of informed consent (for screening and period-related procedures).
- •Non-smoker or past smoker who stopped the use of any form of tobacco, including snuff or similar products, at least 3 months before entering the study.
- •For females, the following conditions had to be met:
- •Had been surgically sterilized or undergone a hysterectomy, or
排除标准
- •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.
研究组 & 干预措施
Trazodone HCl OAD
OAD: Once A Day
干预措施: Trazodone HCl
Trazodone HCl (Apotex Corp.)
干预措施: Trazodone HCl
结局指标
主要结局
Bioequivalence Based Cmax
时间窗: 68 hours
Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).
Bioequivalence Based on AUC(0-tlast)
时间窗: 68 hours
AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration. Measured in nanogram x hours per milliliter (ng\*h/mL).
Bioequivalence Based on AUC(0-∞)
时间窗: 68 hours
AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞). Measured in nanogram x hours per milliliter (ng\*h/mL).
次要结局
- Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)](24 hours)
- Time to Maximum Plasma Concentration (Tmax)(68 hours)
- Apparent Terminal Elimination Rate Constant (λz)(68 hours)
- Apparent Terminal Half-life (t½.z)(68 hours)