Pharmacokinetics of Misoprostol With Titrated Oral Administration

January 27, 2016 updated by: Shi-Yann Cheng, China Medical University Hospital

Phase 1 Study of Titrated Oral Misoprostol

The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Yunlin Xian, Taiwan, 651
        • China Medical University Beigang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 20-40 Y/O healthy and non-pregnant woman

Exclusion Criteria:

  • heart, liver or kidney disease, anaphylaxis to misoprostol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hourly misoprostol
20 microgram misoprostol intake per hour
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Names:
  • cytotec
Active Comparator: traditional misoprostol
80 microgram misoprostol intake per 4 hours
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
Time Frame: 480 min post start of oral misoprostol administration
480 min post start of oral misoprostol administration

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)
Time Frame: 240 min post start of oral misoprostol administration
240 min post start of oral misoprostol administration
AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)
Time Frame: 360 min post start of oral misoprostol administration
360 min post start of oral misoprostol administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Shi-Yann Cheng, M.D., China Medical University Beigang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUBH R990011
  • DMR-IRB-242 (Other Identifier: China Medical University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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