Status and phase
Conditions
Treatments
About
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any finding in the medical examination (Including blood pressure [BP], pulse rate [PR], or electrocardiogram [ECG]) deviating from normal and judged clinically relevant by the investigator.
Any evidence of a concomitant disease judged clinically relevant by the investigator.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders.
History of relevant orthostatic hypotension, fainting spells, or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to the trial medication or it's excipients)
Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication.
Within 14 days prior to the administration of trial medication, use of drugs that might reasonably influence the results of the trial, based on current knowledge
Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication.
Smoker (has used tobacco or nicotine-containing products within 6 months prior to administration of trial medication)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or > 7 alcohol-containing drinks per week)
Drug abuse or positive drug screen
Blood donation (more than 100 ml wihtin 30 days prior to administration of trial medication or intended during the trial)
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study.
For female subjects:
Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion.
No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent, surgically sterile, or post menopausal will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide). Post-menopausal is defined as at least 1 year of spontaneous amenorrhea and deemed post menopausal by a physician based on screening clinical laboratory tests (follicle stimulating hormone and luteinizing hormone).
Lactation
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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