Pharmacokinetics of Misoprostol With Titrated Oral Administration

China Medical University

Status and phase: Completed; Phase 1

Conditions: Hypotonic; Labor

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01271257

DMR-IRB-242 (Other Identifier)

CMUBH R990011

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• heart, liver or kidney disease, anaphylaxis to misoprostol

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

hourly misoprostol

Experimental group

Description:

20 microgram misoprostol intake per hour

Treatment:

Drug: Misoprostol

traditional misoprostol

Active Comparator group

Description:

80 microgram misoprostol intake per 4 hours

Treatment:

Drug: Misoprostol