Phase
Condition
N/ATreatment
repaglinide
midazolam
bupropion
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, asbased on a complete medical history including a physical examination, standardizedmental and neurological assessment, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests withoutclinically significant abnormalities
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial
Either male subjects or female subjects who meet the following criteria requiringhighly effective contraception from at least 30 days before the first administrationof trial medication until 30 days after trial completion:
Use of adequate contraception, i.e. use of condom (male subjects or malepartners of female subjects) plus any of the following methods (female subjectsor female partners of male subjects): intrauterine device, hormonalcontraception (e.g. implants, injectables, combined oral or vaginalcontraceptives), , surgically sterilised (including bilateral tubalocclusion/ligation, hysterectomy, bilateral oophorectomy) or postmenopausal,defined as no menses for 1 year without an alternative medical cause (inquestionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L is confirmatory)
Sexually abstinent (considered a highly effective method only if defined asrefraining from heterosexual intercourse during the entire period of riskassociated with the study treatments)
Vasectomised male subjects or male partners of female subjects (vasectomy atleast 1 year prior to enrolment) in combination with a barrier method (i.e. useof condom) and provided that the partner is the sole sexual partner of thetrial participant Unprotected sexual intercourse (i.e. without use of condom)of a male subject with a pregnant female partner and sperm donation is notallowed throughout the study and until 30 days after trial completion. Femalesubjects should not participate in egg donation from the first trial medicationadministration, for the duration of the study and for at least 30 days aftertrial completion.
Exclusion
Exclusion Criteria:
Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the Upper limit of normal (ULN) after repeated measurements
Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interferewith the pharmacokinetics of the trial medication (except appendectomy or simplehernia repair)
Diseases of the central nervous system (including but not limited to any kind ofseizures or stroke, bulimia or anorexia, or bipolar mood disorder), and otherrelevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts Furtherexclusion criteria apply.
Study Design
Connect with a study center
SGS Life Science Services - Clinical Research
Edegem, 2650
BelgiumSite Not Available
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