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

NCT00816205 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2009-04-07

No results posted yet for this study

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.

Conditions

  • Anal Resting Pressure

Interventions

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.

Sponsors & Collaborators

  • RDD Pharma Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Completion
2009-04-30

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816205 on ClinicalTrials.gov