NCT02157649已完成1 期
An Open-Label, Single-Dose, Crossover Comparative Bioavailability and Pharmacokinetic Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet With Immediate-Release Tablet
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Serum Levels of Codeine and Guaifenesin
研究概览
简要总结
The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking volunteers (Female volunteers on a stable contraceptive medication regimen (> 3 months) may continue during the course of the study but its use must be documented), 18 to 45 years of age, inclusive; Ethnic Group: Arab & Mediterranean.
- •Race: Mixed skin (white & black skin people).
- •Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive;
- •willing and able to comply with the appropriate instructions necessary to complete the study, and;
- •Fully informed of the risks of entering the study and willing to provide written informed consent.
- •Subject is available for the whole study period and gave written informed consent
- •If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control [continuously used for at least 3 months before first dose], or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they have been post - menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) for more than one (1) yearNormal Physical examination.
- •Vital signs within normal ranges.
- •All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
- •Normal Kidney and Liver functions test.
排除标准
- •Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
- •Ethnic Group (Non- Arab &/ or Non- Mediterranean)
- •A significant abnormality in the pre-study physical examination that would place the volunteer at risk during participation in the trial;
- •A clinical laboratory test value outside of the accepted reference range that is deemed by the Investigator to be clinically significant;
- •Require prescription medication on a regular basis;
- •A clinically significant illness during the 28 days prior to Period 1 dosing (as determined by the Investigator);
- •History of serious illness that can impact fate of drugs
- •History of gastrointestinal obstruction, constipation, inflammatory bowel disease, gallbladder disease, pancreas disorder over last 2 years, or recent (over last 3 years) gastrointestinal tract surgery, including gall bladder resection;
- •Known history or presence of cardiac, pulmonary, endocrine, musculoskeletal, neurological, hematological or disease.
- •Subjects with acute pulmonary insufficiency, respiratory depression, acute or chronic severe respiratory insufficiency or history of any of these
- •History of head injury, seizures over last 4 years deemed by the Investigator to be clinically significant;
- •Mental disease
- •History of kidney disease or urination problem over last 2 years deemed by the Investigator to be clinically significant
- •Subjects with renal and/or hepatic insufficiency should be excluded
- •Presence of any significant physical or organ abnormality
- •History of low blood pressure is deemed by the Investigator to be clinically significant;
- •A positive Hepatitis B surface antigen, Hepatitis C antibody screen, or a reactive HIV antibody screen;
- •Known or suspected hypersensitivities, allergies, or other contraindications to Codeine or a related opioid and/or Guaifenesin;
- •History of severe allergy or allergic reactions to study drug or related drugs or heparin
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •Known or suspected history of drug abuse within lifetime as judged by the Investigator;
- •History of alcohol abuse or excessive intake of alcohol within last 5 years as judged by the Investigator;
- •Positive screen for drugs of abuse, alcohol, or cotinine (nicotine) at screening or on admission to the unit prior to administration of investigational products;
- •Use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 2D6 enzymes, within 30 days prior to administration of study formulations. Examples of inducers include: piperidins, carbamazepine, dexamethasone, rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatine, methadone, and ranitidine;
- •Use of prescription medications within 21 days and OTC medications (including vitamins or herbal products) within 7 days (excluding flu vaccination) prior to the first administration of the study medication without Sponsor approval;
- •Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
- •Use of any investigational drug within 30 days prior to first dosing;
- •Use of any tobacco-containing product within 6 months of first dosing;
- •Donated more than 400 mL of blood within 4 weeks before first dosing;
- •Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- •Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- •Abnormal vital signs
- •Abnormal Kidney and Liver functions test.
- •In the opinion of the Investigator, unlikely or unable to successfully complete the study;
- •Volunteer is vegetarian.
- •Vomiting, Diarrhea on admission.
研究组 & 干预措施
ER Tablet under Fasted Conditions
Experimental
Administration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, to subjects under fasted conditions.
干预措施: ER Tablet under Fasted Conditions (Drug)
IR Tablet under Fasted conditions
Active Comparator
IR Tablet combination tablet of Codeine/Guaifenesin 20mg/400mg administered under fasted conditions as a single tablet every 4 hours during a 12 hour study [three doses]
干预措施: IR Tablet under Fasted conditions (Drug)
ER Tablet under Fed Conditions
Experimental
Administration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, following a standard high-fat breakfast.
干预措施: ER Tablet under Fed Conditions (Drug)
结局指标
主要结局
Serum Levels of Codeine and Guaifenesin
时间窗: 20 samples over 24 hours
Blood samples drawn prior to dosing with tablets, then at 19 additional time points over the next 24 hours.
次要结局
- Safety and Tolerability(24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy ParticipantsHealthyNCT02578550Janssen Sciences Ireland UC126
撤回
1 期
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in WomenPharmacokineticsDrug InteractionsHealthyNCT00915668Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Unknown
早期 1 期
Bioavailability of FlucanazoleCandidiasisNCT04502277Sutphin Drugs200
已完成
1 期
Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting ConditionsHealthyNCT01511770Dr. Reddy's Laboratories Limited17
已完成
1 期
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed ConditionsHealthyNCT01511757Dr. Reddy's Laboratories Limited15