A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers

Reckitt Benckiser LLC0 个研究点目标入组 24 人开始时间: 2007年5月5日最近更新: 2019年6月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Reckitt Benckiser LLC
入组人数: 24
主要终点: Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 19 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Males and/or females between the ages of 19 and 55 years, inclusive.
•Females of childbearing potential were using one of the following acceptable birth control methods:
•Intrauterine device (IUD) in place for at least 3 months prior to study;
•Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through 30 days beyond study completion;
•Stable hormonal contraceptive for at least 3 months prior to study through 30 days beyond completion of study;
•Abstinence was not an acceptable form of contraception.
•Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.
•Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.
•Within 15% of Ideal Body Weight as defined by the 1983 Metropolitan Life chart.
•Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year.
•Able to read, understand, and sign the informed consent after the nature of the study had been explained.
•Negative finding on tests for Hepatitis B and C antigen as well as HIV and pregnancy test (if female).
•Negative urine screen for drugs of abuse and alcohol at screening and the first check in.
•Non-alcohol or drug abuser - for alcohol, defined as history of less then 4 drinks daily.

排除标准

•Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
•Females who were pregnant or nursing.
•History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
•Receipt of an investigational drug within 1 month prior to study enrollment.
•Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.
•Known or suspected use of illicit drugs (including codeine or hydrocodone, etc.).
•The use of any medication on a chronic basis with the exception of oral contraceptives for women of childbearing potential. An appropriate drug-free period for prescription or over-the-counter (OTC) drugs provided to washout any especially long half-life drugs.
•Consumption of alcohol within 48 hours prior to each dosing period.
•Consumption of grapefruit 14 days prior to dosing and throughout the study.
•Hemoglobin value < 12 g/dL. If a subject's hemoglobin dropped below 11.0 g/dL the subject was dropped from the study at the Principal Investigator's discretion.

研究组 & 干预措施

Treatment A

Experimental

Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions.

干预措施: Humibid® (Drug)

Treatment B

Experimental

Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state.

干预措施: Hydrocodone Bitartrate (Drug)

Treatment C

Experimental

Hydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state.

干预措施: Humibid® and Hydrocodone Bitartrate tablet (Drug)

结局指标

主要结局

Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin