Pharmacokinetics of Misoprostol With Titrated Oral Administration

Phase 1

Completed

• Conditions: Hypotonic; Labor
• Interventions: Drug: Misoprostol

• Registration Number: NCT01271257
• Lead Sponsor: China Medical University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• heart, liver or kidney disease, anaphylaxis to misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
traditional misoprostol	Misoprostol	80 microgram misoprostol intake per 4 hours
hourly misoprostol	Misoprostol	20 microgram misoprostol intake per hour

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China Medical University Beigang Hospital; 🇨🇳 Yunlin Xian, Taiwan