NCT Number: NCT02222987
Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects
Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.
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Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Healthy male subjects
- Age >= 18 and <= 45 years
- Broca >= -20% and <= +20 %
Exclusion criteria
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- History of
- allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- any bleeding disorder including prolonged or habitual bleeding
- other hematologic disease
- cerebral bleeding (e.g. after car accident)
- commotio cerebri
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol (> 60 g/day) abuse
- Drug abuse
- Blood donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the reference range of clinical relevance
- History of any familial bleeding disorder
- Thrombocytes < 150000/µl
Treatment and study plan
clopidogrel
DrugPrimary outcomes
-
Change in inhibition of platelet aggregation in platelet rich plasma (PRP)
Time frame: baseline, up to day 17
-
Change in thromboxane receptor occupancy (TRO)
Time frame: baseline, up to day 17
-
Change in 6-keto-prostaglandinF-1-alpha
Time frame: baseline, up to day 17
-
Change in thromboxan synthesis inhibition (TSI)
Time frame: baseline, up to day 17
Secondary outcomes
-
Plasma levels of terbogrel
Time frame: up to day 17
-
Number of patients with adverse events
Time frame: up to day 17
-
Change in bleeding time
Time frame: baseline, up to day 17
-
Change in systolic and diastolic blood pressure
Time frame: baseline, up to day 17
-
Change in pulse rate
Time frame: baseline, up to day 17
-
Number of patients with haematuria
Time frame: up to day 17
dipstick test
-
Number of patients with positive Haemoccult test
Time frame: up to day 17
-
Number of patients with clinically significant laboratory findings
Time frame: up to day 17
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.
Important dates
- Study start
- 1999
- Primary completion
- 1999
- First posted
- Aug 22, 2014
- Registry last updated
- Aug 22, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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