|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 April 2013 |
|
Main ID: |
NCT00699777 |
|
Date of registration:
|
16/06/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
|
|
Scientific title:
|
A Randomized, Open-label, 2-period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects |
|
Date of first enrolment:
|
January 2008 |
|
Target sample size:
|
96 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00699777 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
William S Aronstein, PhD/M/FACP |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Procter and Gamble |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- be in good general health based on medical history, physical examination, and
laboratory evaluation
- have a body mass index (BMI) = 32 kg/m2 at screening
Exclusion Criteria:
- has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid
disease
- has any disease or surgery known to alter normal GI structure or function
- has a creatinine clearance of < 60 mL/min, estimated by serum creatinine using the
Cockcroft-Gault formula
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteoporosis
|
|
Intervention(s)
|
|
Drug: Risedronate
|
|
Primary Outcome(s)
|
|
The primary objective is to assess the bioequivalence of one risedronate 150 mg tablet versus two risedronate 75 mg tablets administered as a single oral dose.
[Time Frame: 18-21 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|