NCT00816205

An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: RDD Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.

Detailed description

After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed: The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures. The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from baseline. The secondary efficacy parameters include the following: * The ratio of change in anal pressure to plasma Nifedipine level. * The ratio of change in anal pressure to change in blood pressure. * The ratio of change in anal pressure to change in heart rate.

Conditions

• Anal Resting Pressure

Interventions

Type	Name	Description
DRUG	Coated Nifedipine Suppositories	Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed: The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures. The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine.

Timeline

• Completion: 2009-04-01
• First posted: 2009-01-01
• Last updated: 2009-04-07

Locations

1 site across 1 country: Israel