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Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest

NCT01600274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-03-09

No results posted yet for this study

Summary

* Characterisation of relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions
* Assessment of bioequivalence of Test vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG)
* Descriptive characterisation of safety and tolerability of the investigational products in the study population

Conditions

  • Focus: Bioequivalence

Interventions

DRUG

Dienogest-Ethinyl Estradiol (test product)

One tablet of Test

DRUG

Dienogest-Ethinyl Estradiol (reference product)

One tablet of Reference

Sponsors & Collaborators

  • Pharbil Waltrop GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Donath, PhD · SocraTec R&D GmbH - Clinical Pharmacology Unit Mainzerhofplatz 14, 99084 Erfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Germany

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 NCT01600274 on ClinicalTrials.gov