The Effect of Losartan on Cephalexin
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentrations of cephalexin over time, the cumulative urinary excretion of cephalexin, and the pharmacokinetic parameters derived from these measurements following simultaneous or staggered ingestion of losartan
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of the blood pressure-lowering drug losartan on the blood levels and urinary excretion of the antibiotic cephalexin during simultaneous and staggered ingestion in healthy volunteers. The main questions it aims to answer are:
- Does losartan affect cephalexin levels and excretion when ingested at the same time?
- Does a three-hour interval between ingestion of losartan and cephalexin eliminate a possible effect?
Researchers will compare the effects of losartan ingested at the same time, losartan ingested three hours prior, and no losartan ingested on oral cephalexin in each participant to see whether an interaction exists and could be avoided.
Participants will visit the research laboratory on three days during which they will ingest single doses of losartan at the same time with, three hours prior to, and not at all prior to ingesting single doses of cephalexin.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •18-40 years of age
- •good health
- •systolic blood pressure of at least 115 mmHg
- •all screening laboratory results (P-Krea, Pt-GFReEPI, P-Na, P-K, P-ALAT, P-AFOS, P-GT, B-PVK+T) acceptable; minor deviations from reference ranges are acceptable at the discretion of a physician-scientist with the exceptions of Pt-GFReEPI which must be at or above the reference limit and P-K which must be at or below the higher reference limit (Reference limits: Tyks Laboratories, Turku University Hospital)
- •regarding female subjects, a negative pregnancy test (S-HCG-O) before the study, and the use of a highly effective contraceptive method (e.g. copper intrauterine device, bilateral tubal occlusion, vasectomised partner, or abstinence from heterosexual intercourse), according to CTFG Recommendations related to contraception and pregnancy testing in clinical trials, are required
排除标准
- •inability to provide written informed consent in Finnish
- •remarkable illness
- •confirmed or reasonably suspected allergy to cephalexin, amoxicillin, benzylpenicillin, phenoxymethylpenicillin, piperacillin, cefaclor, or cefamandole
- •confirmed or reasonably suspected severe delayed allergic reaction to any beta-lactam antibiotic
- •underweight (BMI less than 18.5 kg/m2)
- •obesity (BMI greater than 30 kg/m2)
- •regular medication, including hormonal contraception in the form of pills, intrauterine device, subdermal implant etc.
- •current or planned pregnancy, and breastfeeding
- •less than three months elapsed since a prior clinical trial
- •less than three months elapsed since donating blood
研究组 & 干预措施
Sequence E
water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
Sequence F
losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence A
water at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence A
water at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
Sequence B
water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence B
water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
Sequence C
losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence C
losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
Sequence D
water at 7.30, cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence D
water at 7.30, cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
Sequence E
water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30; then losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30
干预措施: losartan (Drug)
Sequence F
losartan 100 mg at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, cephalexin 500 mg at 10.30; then water at 7.30, losartan 100 mg and cephalexin 500 mg at 10.30
干预措施: cephalexin (Drug)
结局指标
主要结局
Plasma concentrations of cephalexin over time, the cumulative urinary excretion of cephalexin, and the pharmacokinetic parameters derived from these measurements following simultaneous or staggered ingestion of losartan
时间窗: up to 8 hours after ingestion of cephalexin on three consecutive days separated by at least one-week intervals
次要结局
- Plasma concentrations of losartan and losartan carboxylic acid over time, the cumulative urinary excretion of losartan and losartan carboxylic acid, and the pharmacokinetic parameters derived from these measurements(up to 11 hours after ingestion of losartan or water on three consecutive days separated by at least one-week intervals)
研究者
Aleksi Tornio
Chief Physician
Turku University Hospital