Status:
COMPLETED
Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Anaphylaxis
Eligibility:
All Genders
18-54 years
Phase:
PHASE1
Brief Summary
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
Detailed Description
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD...
Eligibility Criteria
Inclusion
- Healthy male and female subjects, between 18 and 54 years of age (inclusive).
- Subjects who are able and willing to give written informed consent.
- Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may not have changed by more than 3 kg compared to screening.
- Compressed STMD of 10 mm and above (Part 1+2).
- Non-smoker for at least 6 months.
Exclusion
- Receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen.
- Receipt of any of the following medications within the previous 6 months; beta adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and catechol-O-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs that may sensitize the heart to arrhythmias, including digitalis and quinidine.
- History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
- History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B or C.
- Presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).
Key Trial Info
Start Date :
March 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03282929
Start Date
March 23 2017
End Date
October 15 2018
Last Update
June 21 2019
Active Locations (1)
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1
Nuvisan GmbH
Neu-Ulm, Wegenerstrasse 13, Germany, 89231