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Comparative Bioavailability Study of Two Misoprostol Formulations

NCT02516631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-12-06

No results posted yet for this study

Summary

The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.

Conditions

  • Labour, Induced

Interventions

DRUG

Angusta™

One tablet of Angusta™ (25 µg) given every 2 hours

DRUG

Cytotec®

1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced.

DRUG

Angusta™

Two tablets of Angusta™ 25 µg given every 4 hours

DRUG

Cytotec®

¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.

DRUG

Angusta™

Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours

DRUG

Cytotec®

¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Dag Wide-Swensson · Region Skåne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2016-02-29

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02516631 on ClinicalTrials.gov