NCT00779805已完成不适用
An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.
详细描述
This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions.
A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be in the age range of 18 - 45 years
- •Be neither over weight nor under weight for his/ her height as per the Life Insurance Corporation of India height/ weight chart for non-medical cases
- •Have voluntarily given written informed consent to participate in this study
- •Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study
- •If female and:
- •Of child bearing potential is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
- •Is postmenopausal for at least 1 year; or
- •Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
排除标准
- •History of allergy to Pseudoephedrine or other sympathomimetic drugs
- •History of intake of any sympathomimetic drugs and glucocorticoids during a period of 15 days prior to day 1 of this study.
- •Concurrent use of monoamine oxidase inhibitor (MAOI) drugs within 14 days prior to day 1 of this study
- •Any evidence of organ dysfunction or any clinically significant deviations from the normal, in physical or clinical determinations
- •Presence of disease markers of HIV 1 or 2, hepatitis B or C viruses or syphilis infection
- •Female volunteers demonstrating a positive pregnancy test
- •Female volunteers who are currently breastfeeding
- •Presence of values which are significantly different from normal reference ranges (as defined in appendix 5) and/ or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol
- •Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/ HPF), glucose (positive) or protein (positive)
- •Clinically abnormal ECH or chest X-ray
- •History of serious gastrointestinal, hepatic, renal, pulmonary, neurological or hematological diseases or glaucoma
- •History of cardiovascular disorders (including hypertension), endocrine disorders, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, palpitations, insomnia, tremors or bronchial asthma
- •History of any psychiatric illness which may impair the ability to provide written informed consent
- •Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- •History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period
- •Use of any enzyme modifying drugs within 30 days prior to day 1 of this study
- •Participation in any clinical trail within 12 weeks preceding day 1 of this study
- •Subjects who, through completion of this study, would have donated and / or lost more than 350 mL of blood in the past 3 months.
研究组 & 干预措施
1
Experimental
Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy
干预措施: Pseudoephedrine hydrochloride 120 mg ER tablets (Drug)
2
Active Comparator
Sudafed 120 mg ER tablets
干预措施: Pseudoephedrine hydrochloride 120 mg ER tablets (Drug)
结局指标
主要结局
Bioequivalence
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting ConditionsHealthyNCT00779831Ranbaxy Laboratories Limited36
已完成
1 期
Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting ConditionsHealthyNCT01131780Dr. Reddy's Laboratories Limited32
已完成
1 期
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed ConditionsHealthyNCT01132222Dr. Reddy's Laboratories Limited34
已完成
1 期
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed ConditionsHealthyNCT01267383Dr. Reddy's Laboratories Limited32
已完成
1 期
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting ConditionsHealthyNCT01267396Dr. Reddy's Laboratories Limited32