A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
Study Details
Study Description
Brief Summary
To establish the bioequivalence of alteplase derived from two different manufacturing processes.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part B: Test treatment (T)
|
Drug: Alteplase (from modified manufacturing process)
Alteplase
Drug: Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
|
Active Comparator: Part B: Reference treatment (R)
|
Drug: Alteplase (from current manufacturing process)
Alteplase
Drug: Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
|
Experimental: Part A: Test Open-label |
Drug: Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
|
Outcome Measures
Primary Outcome Measures
- AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [up to 6 hours]
- Cmax (maximum measured concentration of the analyte in plasma) [up to 6 hours]
Secondary Outcome Measures
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 6 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
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Age of 18 to 45 years (inclusive)
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Body mass index (weight divided by height squared) (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
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Body weight of 65 - 100 kg (inclusive) at screening
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Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
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Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
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Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
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Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, e.g. thrombotic predisposition according to thrombophilic testing
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Any evidence of a concomitant disease assessed as clinically relevant by the investigator
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Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
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History of relevant orthostatic hypotension, fainting spells, or blackouts
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Chronic or relevant acute infections
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History of relevant allergy or hypersensitivity
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During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection Further exclusion criteria apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Humanpharmakologisches Zentrum Biberach | Biberach | Germany | 88397 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0135-0340
- 2019-004932-40