A single center, randomized, partially blind, placebocontrolled, crossover, single oral dose study to assess theeffect of concomitant antacid (calcium carbonate) on thepharmacokinetics and pharmacodynamics of SMC021 (0.8mg salmon calcitonin/200 mg 5-CNAC) in healthypostmenopausal wome

• Conditions: Osteoporosis, osteoarthritis; MedDRA version: 8.1Level: LLTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2006-004177-95-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 38

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of calcium carbonate / magnesium hydroxide on the pharmacokinetics and<br>pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-<br>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<br>hydroxide) on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC)