Pharmacokinetics of Misoprostol With Titrated Oral Administration

Phase 1 Study of Titrated Oral Misoprostol

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271257

Enrollment

Registered

2011-01-06

Start date

2011-01-31

Completion date

2014-12-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotonic; Labor

Keywords

misoprostol, pharmacokinetics

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.

Interventions

DRUGMisoprostol

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* heart, liver or kidney disease, anaphylaxis to misoprostol

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026