Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2026-02-28
2026-04-30
Brief Summary
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1. Does losartan affect cephalexin levels and excretion when ingested at the same time?
2. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
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
losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
Interventions
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losartan
100 mg tablet orally, single dose
cephalexin
500 mg tablet orally, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 P-Krea and P-K which must be at or below the higher reference limit, and Pt-GFReEPI which must be at or above the 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 an acceptable contraceptive method (e.g. condom, copper intrauterine device or abstinence from heterosexual intercourse), according to CTFG Recommendations related to contraception and pregnancy testing in clinical trials, are required
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
University of Turku
OTHER
University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
Aleksi Tornio
OTHER_GOV
Responsible Party
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Aleksi Tornio
Chief Physician
Principal Investigators
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Aleksi Tornio, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Unit of Clinical Pharmacology, Turku University Hospital
Locations
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Unit of Clinical Pharmacology, Turku University Hospital
Turku, Southwest Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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Aleksi Tornio, M.D., Ph.D.
Role: primary
Other Identifiers
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KEFALOS
Identifier Type: -
Identifier Source: org_study_id