NCT00649987
已完成
1 期
Single-Dose Fed Bioequivalence Study of Albuterol Sulfate Extended-Release Tablets (8 mg; Mylan) and VoSpire® ER Tablets (8 mg; Pliva) in Healthy Volunteers
适应症Healthy
概览
- 阶段
- 1 期
- 干预措施
- Albuterol Sulfate Extended-Release Tablets 8 mg
- 疾病 / 适应症
- Healthy
- 发起方
- Mylan Pharmaceuticals Inc
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Bioequivalence
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.
研究者
入排标准
入选标准
- •Age: 18 years and older.
- •Sex: Male and/or non-pregnant, non-lactating female.
- •Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing for each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.
- •Women must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
- •(1) intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or (2) barrier methods containing or used in conjunction with a spermicidal agent, or (3) surgical sterilization
- •Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- •postmenopausal with an absence of menses for at least one (1) year, or
- •bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •total hysterectomy
- •During the course of the study, from study screen until study exit - including the washout period, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •Use of any tobacco-containing products within 1 year of the start of the study.
- •Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- •Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- •Any recent, significant change in dietary or exercise habits.
- •A positive test for any drug included in the urine drug screen.
- •History of drug and/or alcohol abuse.
- •Medications:
- •Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
研究组 & 干预措施
1
Albuterol Sulfate Extended-Release Tablets 8 mg
干预措施: Albuterol Sulfate Extended-Release Tablets 8 mg
2
VoSpire® ER Tablets 8 mg
干预措施: VoSpire® ER Tablets 8 mg
结局指标
主要结局
Bioequivalence
时间窗: within 30 days
研究点 (1)
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