The Effect of Losartan on Cephalexin

NCT ID: NCT07300670

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Possible Interaction Between Losartan and Cephalexin Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

losartan cephalexin pharmacokinetic interaction absorption

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

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

Group Type OTHER

losartan

Intervention Type DRUG

100 mg tablet orally, single dose

cephalexin

Intervention Type DRUG

500 mg tablet orally, single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

losartan

100 mg tablet orally, single dose

Intervention Type DRUG

cephalexin

500 mg tablet orally, single dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cozaar Kefalex Kefexin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Aleksi Tornio

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aleksi Tornio

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aleksi Tornio, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Unit of Clinical Pharmacology, Turku University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unit of Clinical Pharmacology, Turku University Hospital

Turku, Southwest Finland, Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aleksi Tornio, M.D., Ph.D.

Role: CONTACT

Phone: +358504765715

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aleksi Tornio, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEFALOS

Identifier Type: -

Identifier Source: org_study_id