NL-OMON42209CompletedNot Applicable
A SINGLE AND MULTIPLE ASCENDING DOSE TRIAL INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORALLY ADMINISTERED SP-35454 IN HEALTHY POSTMENOPAUSAL WOMEN - SAD and MAD of SP-35454 in healthy postmenopausal women
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shin Poong Pharm. Co. Ltd
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •1. Healthy, postmenopausal women.;2. Menopausal status recognized as:;• >=12 months of spontaneous amenorrhea;;• at least 6 months of amenorrhea with serum follicle stimulating hormone (FSH) levels of >= 40 mlU/mL;;• FSH levels of >= 40 mlU/mL following washout of hormone replacement therapy if the menopausal status was not previously confirmed.;3. Age between 45-70 years inclusive at the time of the first dosing administration.;4. Body Mass Index (BMI) 18.0-30.0 kg/m2 (extremes included) at screening).;5. Good physical and mental health as established by medical history and physical examination and electrocardiogram (ECG) and vital signs recording, results of biochemistry, hematology and urinalysis testing within 21 days prior to the first dose as judged by the Investigator.;6. Subject is a non-smoker for at least 3 months prior to dosing, to be confirmed by a urine cotinine dipstick test.;7. Subject has a negative urine pregnancy test at screening.;8. Washout period from previous treatment for osteoporosis (e.g. oral estrogen and/or progestagen, tibolone or raloxifene or any bisphosphonates) of at least 8 weeks at first dosing.;9. Availability and willingness to complete the study and follow the instructions of the Investigator or trial personnel.;10. Easy venous accessibility.;11. Ability and willingness to sign the ICF prior to screening evaluations.
Exclusion Criteria
- •1. Clinically relevant abnormal laboratory, ECG recordings, vital signs or physical or mental findings at screening as judged by the Investigator. ;2. Clinically significant presence or history of allergy as judged by the Investigator.;3. Positive serology for hepatitis B antigen, hepatitis C antibodies, human immunodeficiency virus (HIV) 1 or HIV-2.;4. History of alcohol or drug abuse within the last 2 years.;5. History of cancer.;6. Surgery of gastro-intestinal tract that might interfere with absorption.;7. Any medication including over the counter products and herbal medications or dietary supplements including products containing Hypericum perforatum (e.g., St. John*s wort) from 14 days prior to Day -1 of the first dosing period, except for occasional paracetamol.;8. Intake of any enzyme affecting drugs from 30 days prior to Day -1 of the first dosing period.4;9. Fluoride therapy for more than 3 months during the previous 2 years.;10. Participation in a trial of an investigational product in the preceding 3 months prior to the first dose or during this trial.;11. Blood donation or blood loss of more than 400 mL in the preceding 3 months before first dosing.;12. Major surgery, fracture, prolonged immobilization (more than 2 weeks) within the 3 months preceding screening.;13. History of hypersensitivity or idiosyncrasy to any of the components of the investigational drug.;14. Positive drug, alcohol or cotinine test at screening and/or admission (Day -1 of the first dosing period). Urine will be tested for the presence of benzodiazepines, opiates, amphetamines, cocaine, cannabinoids, and barbiturates.
Investigators
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