Osteoporosis, osteoarthritis MedDRA version: 8.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Product Name: oral calcitonin
Product Code: SMC021
Pharmaceutical Form: Tablet
INN or Proposed INN: Calcitonin
Other descriptive name: salmon calcitonin
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Female volunteers between the ages of 40 and 70 years with a weight at least 50 kg and a BMI of 18-30, at least 5 years after natural menopause or 6 months after surgical menopause. Menopause will be confirmed by plasma FSH level of >40IU/L. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from entry into or continuation in the study unless sponsor approval is obtained: 1. Smokers who report cigarette use of = 5 cigarette per day. Smoking will not be allowed on the days of each dosing up to the last blood sampling or the last assessment. 2. Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening. All concomitant medication must be taken at a stable dose throughout the study. Paracetamol is acceptable as on/off treatment, but must be documented in the Concomitant medications/Significant non-drug therapies page of the CRF. 3. Participation in any clinical investigation within 4 weeks prior to dosing, or less than 10 times the corresponding half life of the drug taken, whichever is longer, or longer if required by local regulations, and for any other limitation of participation based on local regulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of calcium carbonate / magnesium hydroxide on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5- CNAC);Secondary Objective: To assess the tolerability of concomitantly-administered antacid and SMC021;Primary end point(s): To determine the effect of concomitant antacid (calcium carbonate / magnesium hydroxide) on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC) | — |
Countries
Denmark
Outcome results
None listed