Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Singl… (NCT01976572) | Clinical Trial Compass
CompletedPhase 1
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
United Kingdom18 participantsStarted 2013-10
Plain-language summary
The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan administered at doses of 5 g three times daily compared to administration of candesartan cilexetil alone, in healthy subjects.
Who can participate
Age range18 Years – 50 Years
SexMALE
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Inclusion Criteria:
* Able to provide written informed consent to participate in this study, after reading the participant information sheet and informed consent form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
* Caucasian male subjects aged 18 to 50 years inclusive.
* A body mass index (BMI) between 18.0 and 32.0 kg/m2, both inclusive.
* Healthy subjects, free from any clinically significant illness or disease as determined by their medical history, physical examination, electrocardiogram (ECG), vital signs, biochemistry, haematology, coagulation, urinalysis, and serology.
* Male subjects, and their partners, agree to use contraception throughout the study duration. Male subjects must use 1 barrier method of contraception and spermicide during the trial, and for 3 months after the last dose of study drug. Male subjects with female partners of child-bearing potential must also agree to use an additional highly effective method of contraception. They must use a condom, and their female partners must use an additional method of contraception (such as cap or diaphragm), unless the subject or his partner has been sterilised, in which case, male subjects must use a condom and spermicide.
Exclusion Criteria:
* Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration, as determined by the Investigator based on abnormal medical history, physical findings, or laboratory values at Sc…