Comparative Bioavailability Study of Two Misoprostol Formulations
NCT ID: NCT02516631
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2014-11-30
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour.
The drug shall be administered orally or sublingually.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral (A)
One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg).
Angusta™
One tablet of Angusta™ (25 µg) given every 2 hours
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.
Oral (B)
Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®.
Angusta™
Two tablets of Angusta™ 25 µg given every 4 hours
Cytotec®
¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
Sublingual (C)
Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg.
Angusta™
Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Angusta™
One tablet of Angusta™ (25 µg) given every 2 hours
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.
Angusta™
Two tablets of Angusta™ 25 µg given every 4 hours
Cytotec®
¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
Angusta™
Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women wanting to participate and having given informed consent
* Known to have reached week 37 + 0 days to week 42 + 2 days of gestation
* With a viable fetus in a vertex position
* Age above or equal to 18 years old
* Women opting for vaginal delivery
* BMI between 20 and 30 kg/m2
Exclusion Criteria
* Women with prior caesarean section
* Women with dead or anomalous fetus
* Women with twin pregnancy
* Women with known liver or renal dysfunction
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region Skane
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dag Wide-Swensson
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Skåne University Hospital Lund
Lund, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Amini M, Reis M, Wide-Swensson D. A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration. Front Pharmacol. 2020 Feb 12;11:50. doi: 10.3389/fphar.2020.00050. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AZ-201
Identifier Type: -
Identifier Source: org_study_id