MedDRA - 10044755: Tuberculosis A15
Conditions
Interventions
Group 1: 1 capsule (à 250 mg terizidone) on day 1, 1 capsule (à 250 mg terizidone) every 8 hours from day 4 to day 8
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: male and female volunteers, aged 18-45 years Caucasian origin BMI >= 19 kg/m² and <= 27 kg/m² good health as evidenced by the results of the clinical examination and the laboratory check-up which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state written informed consent given by volunteer after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
Exclusion criteria
Exclusion criteria: results of the medical examination or laboratory screening which are judged by the clinical investigator to differ in a clinically relevant way from the normal state female subjects of childbearing potential not willing to use a combination of e.g. hormonal and barrier methods of contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tube ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status volunteers with existing cardiac or hematological diseases and/ or pathological findings which might interfere with safety, pharmacodynamic effect and/ or pharmacokinetics of terizidone volunteers with existing gastrointestinal diseases and/ or pathological findings which might interfere with safety, pharmacodynamic effect and/ or pharmacokinetics of terizidone acute or chronic diseases which could affect drug absorption or metabolism volunteers with hepatic and/or pancreas diseases volunteers with renal diseases volunteers liable to orthostatic dysregulation, fainting, or blackout volunteers with known allergic reactions to the investigational products and their adjuvants volunteers positive of HBsAG, HIV and /or drugs volunteers with a history of drug addiction and alcohol dependency high grade cerebral sclerosis history of existing psychic / mental disorders (depressions, other psychotic disorders) epilepsy gravidity breast feeding mothers, lactation alcohol consumption more than 20 g/day special or uniform nutritional habits, e.g. vegetarians or undercaloric diet intake of grapefruit containing food or beverages and poppy seeds containing products will not be allowed 14 days prior to the first drug administration and until the last blood sampling of the study volunteers with uncommon physical exercise (competitive athletes), excessive physical activity one week before the trial excessive smoking (more than 10 cigarettes or equivalents per day) less than 14 days after last acute disease less than 14 days after last systemic or local drug administration or less than 10 half-lives of the respective drugs blood donation within the last 3 months blocking time due to another clinical trial with investigational products volunteers suspected or known not to follow instructions volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective of the study is the assessment of single and multiple dose pharmacokinetics of terizidone and its main metabolite cycloserine in healthy volunteers during a period of 11 days. | — |
Countries
Germany
Contacts
Public ContactWerner Siegmund
Ernst Moritz Arndt University Department of Pharmacology
Outcome results
None listed