Pharmacokinetic/Pharmacodynamic (PK/PD) Study to Evaluate Adrenaline (Epinephrine) Exposure Following Intramuscular Administration of Fastjekt® Auto-Injector (0.3 mg; Mylan) in Adult Volunteers with Varying Skin to Muscle Distance (STMD) in the Thigh
- Conditions
- healthy volunteers
- Registration Number
- DRKS00011263
- Lead Sponsor
- Mylan Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 35
1.Age:18 to 55 years old (inclusive).
2.Sex:Males and/or non-pregnant, non-lactating females.
a.Females must have a negative serum ß-HCG pregnancy test performed within 28 days prior to
the start of the study and follow the contraceptive requirements outlined in the protocol
b.Women will not be considered of childbearing potential if one of the criteria specified in the protocol is reported and documented on the medical history (e.g. postmenopausal, bilateral oophorectomy, total hysterectomy).
3.Weight:At least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women with all subjects having a Body Mass Index (BMI) greater than or
equal to 18 kg/m2 but less than or equal to 40 kg/m2.
4.Smoking Status: Non-smokers to light-smokers will be eligible to participate in this study.
5.Must be able to read, speak and understand German language.
6.Must be able to provide written consent.
7.Agree to undergo all anthropomorphic measurements during Screening
outlined in the protocol.
8.All subjects should be judged by the Investigator as capable of safely participating in the study during a pre-study medical evaluation performed within 28 days of the initial
dose of study medication which will include:
a. a normal or non-clinically significant physical examination, including vital signs, as specified in the protocol; b. an echocardiogram and a graded exercise stress test without perfusion imaging; c. within normal limits or non-clinically significant laboratory evaluation results for the following tests (unless otherwise noted in the Exclusion
Criteria): Serum chemistries, hematology, urinalysis and hormones; d. negative Hepatitis B antigen and Hepatitis C antibody tests; e. negative HIV test; f. normal or non-clinically significant ECG (as specified in protocol);
g. negative urine drug screen as specified in the protocol; h. if warranted, other tests and/or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
1.Vulnerable subject, e.g., kept in detention, protected adults under guardianship, trusteeship or committed to an institution by
governmental or juridical order.
2.Social Habits: a. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
b. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
c. Any recent, significant change in dietary or exercise habits.
d. History of drug and/or alcohol abuse within one year of start of study.
3.Medications:
a. Use of any prescription or over-the-counter (OTC) medications (particularly specified in the protocol) within the 14 days prior to the initial dose of study medication, except for any necessary medication for which dosing has been stabilized for a period of at least 30 days and is expected to remain stable for the entire study and will not interfere with subject response to adrenaline as determined by the Investigator.
b. Use of any medication known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial dose of study medication, except for any necessary medication for which dosing has been stabilized for a period of at least 30 days and is expected to remain stable for the entire study and will not interfere with subject response to adrenaline as determined
by the Investigator.
4. Diseases:
a. History of any cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, musculoskeletal disease or malignancies deemed clinically
significant to which subject safety would be of concern as determined by the Investigator.
b. History of angina pectoris, obstructive cardiomyopathy, dysrhythmia, cor pulmonale and atherosclerosis
c. Presence of hypercalcemia or hypokalemia
d. Presence or history of diabetes mellitus, hyperthyroidism and hypertension
e. Known history of glaucoma or intraocular pressure above 18 mmHg within the last 6 months
f. Severe renal impairment or prostatic adenoma leading to residual urine
g. Presence or history of phaeochromocytoma
h. Parkinson’s disease
i. History of (bronchial) asthma
j. Known family history of close relatives with an early sudden death that was heart-related.
k. Known history of prior tuberculosis infection, or any contact within the past 2 years with person with active tuberculosis.
l. Acute illness at the time of either the pre-study medical evaluation or dosing.
m. History of severe allergic reaction, particularly to any sulfites.
5. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
6. Intolerance to venipuncture or unsuitable venous status.
7. Donation or loss of blood or plasma as specified in the protocol prior to the initial dose of study medication.
8. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
9. Damaged skin in or around injection sites (as specified in the protocol)
10. Allergy or hypersensitivity to adrenaline, sodium metabisulfite or any inactive ingredients.
11. Subjects with a systolic and/or diastolic inter-arm difference of = 10 mmHg at Screening (will be determined by the median of three assessments).
12. Consumption of grapefruit, grapefruit-like or grapefruit-containing products within 7 days of drug administration.
13.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Single-dose pharmacokinetic parameters for adrenaline (baseline-corrected and -uncorrected), will be calculated using non-compartmental techniques at pre-defined time points from Day -1 to 360 miniutes post dose.
- Secondary Outcome Measures
Name Time Method Single-dose pharmacodynamic parameters (heart rate, systolic and diastolic blood pressure) for adrenaline will be baseline-corrected at pre-defined time points on Day 1 (until 180 minutes post dose).