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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-525059-23-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| University of Turku | OTHER |
| University of Helsinki | OTHER |
| Helsinki University Central Hospital |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | 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 |
|
| Sequence B | Other | 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 |
|
| Sequence C | Other | 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 |
|
| Sequence D | Other | 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 |
|
| Sequence E | Other | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan | Drug | 100 mg tablet orally, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 8 hours after ingestion of cephalexin on three consecutive days separated by at least one-week intervals |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urinary concentrations of endogenous and diet-derived metabolites, and the effects of genetic variants and other individual factors on the pharmacokinetic parameters of cephalexin and losartan | up to 11½ hours on three consecutive days separated by at least one-week intervals |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksi Tornio, M.D., Ph.D. | Contact | +358504765715 | aleksi.tornio@utu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Aleksi Tornio, M.D., Ph.D. | Unit of Clinical Pharmacology, Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Clinical Pharmacology, Turku University Hospital | Recruiting | Turku | Southwest Finland | FI-20520 | Finland |
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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| ID | Term |
|---|---|
| D019808 | Losartan |
| D002506 | Cephalexin |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
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| Sequence F | Other | 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 |
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| cephalexin | Drug | 500 mg tablet orally, single dose |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |