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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01916330
Other study ID # SNUHOB-PK1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2013

Study information

Verified date April 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date
Est. primary completion date February 24, 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- 20 <= age < 50

- pregnant women who were administered intramuscular dexamethasone (ex) preterm labor)

- pregnant women who were administered PO clarithromycin (ex) PPROM/intrauterine infection or inflammation)

Exclusion Criteria:

- who deny the study entrance

- who administered study drug before transfer to tertiary hospital

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of drug concentration drug (dexamethasone, clarithromycin) Day 1 after delivery
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