Effekten af Losartan på Cephalexin (KEFALOS)
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Southwest Finland
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Turku, Southwest Finland, Finland, FI-20520
- Unit of Clinical Pharmacology, Turku University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- smoking
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
|
Andet: 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 |
100 mg tablet orally, single dose
Andre navne:
500 mg tablet orally, single dose
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasmakoncentrationer af cefalexin over tid, den kumulative urinudskillelse af cefalexin og de farmakokinetiske parametre afledt af disse målinger efter samtidig eller forskudt indtagelse af losartan
Tidsramme: op til 8 timer efter indtagelse af cefalexin på tre på hinanden følgende dage adskilt af mindst en uges intervaller
|
op til 8 timer efter indtagelse af cefalexin på tre på hinanden følgende dage adskilt af mindst en uges intervaller
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: up to 11 hours after ingestion of losartan or water on three consecutive days separated by at least one-week intervals
|
following simultaneous and staggered ingestion of cephalexin |
up to 11 hours after ingestion of losartan or water on three consecutive days separated by at least one-week intervals
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma- og urinkoncentrationer af endogene og kostafledte metabolitter samt effekterne af genetiske varianter og andre individuelle faktorer på de farmakokinetiske parametre for cefalexin og losartan
Tidsramme: op til 11½ time over tre på hinanden følgende dage med mindst en ugers mellemrum
|
op til 11½ time over tre på hinanden følgende dage med mindst en ugers mellemrum
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Aleksi Tornio, M.D., Ph.D., Unit of Clinical Pharmacology, Turku University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Svovlforbindelser
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Kulbrinter, aromatisk
- Imidazoler
- Amider
- Benzenderivater
- beta-lactams
- Lactams
- Cephalosporiner
- Thiazines
- Tetrazoler
- Biphenylforbindelser
- Cephalexin
- Losartan
Andre undersøgelses-id-numre
- T2025/25858
- 2025-525059-23-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The individual data supporting the findings of this study cannot be made available to other researchers to protect the privacy of the study subjects in accordance with European legislation and ethical requirements.
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