Pharmacokinetics of Misoprostol With Titrated Oral Administration

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shi-Yann Cheng, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01271257
First received: January 5, 2011
Last updated: February 17, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Hypotonic; Labor
Drug: Misoprostol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Titrated Oral Misoprostol

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: cytotec

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • heart, liver or kidney disease, anaphylaxis to misoprostol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271257

Locations
Taiwan
China Medical University Beigang Hospital
Yunlin Xian, Taiwan, 651
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shi-Yann Cheng, M.D. China Medical University Beigang Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Shi-Yann Cheng, Director of Department of Obstetrics and Gynecology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01271257     History of Changes
Other Study ID Numbers: CMUBH R990011, DMR-IRB-242
Study First Received: January 5, 2011
Last Updated: February 17, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
misoprostol, pharmacokinetics

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 19, 2014