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OpenTrials
Completed

NCT Number: NCT01271257

Pharmacokinetics of Misoprostol With Titrated Oral Administration

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

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Key information

Conditions

Hypotonic; Labor

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

China Medical University Beigang Hospital

Yunlin Xian, Taiwan, 651

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • heart, liver or kidney disease, anaphylaxis to misoprostol

Treatment and study plan

Misoprostol

Drug

20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses

Other names: cytotec

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Phase 1 Study of Titrated Oral Misoprostol

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2011
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.