NCT00836004已完成1 期
Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin Hcl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fed Conditions
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age.
- •Non-child-bearing potential female subject is defined as follows:
- •Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
- •Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
- •Capable of consent.
排除标准
- •Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Any clinically significant abnormality found during the medical screening.
- •Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- •Abnormal laboratory tests judged clinically significant.
- •Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- •EGC abnormalities (clinically significant) or vital sign abnormalities(systolic blood pressure lower than 90 over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- •BMI≥ 30.0kg/m
- •History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol) or positive alcohol breath test at screening.
- •History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- •History of allergic reactions to clindamycin or other related drugs (e.g. lienomycin).
- •History of allergic reactions to heparin.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- •Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- •Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, haematologic, immunologic, psychiatric, or metabolic disease.
- •Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products ( including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Difficulty to swallow study medication.
- •Use of any tobacco products in the 90 days preceding drug administration.
- •Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Subinvestigator, contraindicate the subjects's participation in this study.
- •A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- •Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
- •less than 300 mL or whole blood within 30 days,
- •300 mL to 500 mL of whole blood within 45 days,
- •more than 500 mL of whole blood within 56 days prior to drug administration.
- •Intolerance to venipunctures.
- •Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
- •Subjects unable to understand or unwilling to sign the Informed Consent Form.
- •Clinically significant history of diarrhea subsequent to administration or antibacterial agents or antibiotics.
- •Additional exclusion criteria for females only:
- •Breast-feeding subject.
- •Positive urine pregnancy test at screening
- •Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 says prior to study drug administration. Acceptable methods of contraception:
- •condom + spermicide,
- •diaphragm + spermicide,
- •intra-uterine contraceptive devise (placed at least 4 weeks prior to study drug administration.
研究组 & 干预措施
Clindamycin (test)
Experimental
Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
干预措施: Clindamycin 300 mg capsule (Drug)
Cleocin® (reference)
Active Comparator
Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
干预措施: Cleocin HCl 300 mg capsules (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 24 hour period
Bioequivalence based on Cmax
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 24 hour period
Bioequivalence based on AUCinf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
次要结局
未报告次要终点
研究者
研究点 (1)
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