Comparative Bioavailability Study of Two Misoprostol Formulations

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

February 29, 2016

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.

Trial Locations (1)

Unknown

Skåne University Hospital Lund, Lund

All Listed Sponsors
lead

Region Skane

OTHER

NCT02516631 - Comparative Bioavailability Study of Two Misoprostol Formulations | Biotech Hunter | Biotech Hunter