Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest

NCT ID: NCT01600274

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-02-28

Brief 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

Detailed Description

The aims of this study were to characterise relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions and to assess 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 maximal concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG). Furthermore, a descriptive characterisation of safety and tolerability of the investigational products in the study population was performed.

Conditions

Focus: Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diena

Dienogest-Ethinyl Estradiol (test product) tablet

Group Type: EXPERIMENTAL

Dienogest-Ethinyl Estradiol (test product)

Intervention Type: DRUG

One tablet of Test

Valette®

Dienogest-Ethinyl Estradiol (reference product) tablet

Group Type: ACTIVE_COMPARATOR

Dienogest-Ethinyl Estradiol (reference product)

Intervention Type: DRUG

One tablet of Reference

Interventions

Dienogest-Ethinyl Estradiol (test product)

One tablet of Test

Intervention Type: DRUG

Dienogest-Ethinyl Estradiol (reference product)

One tablet of Reference

Intervention Type: DRUG

Other Intervention Names

Diena; Valette®

Eligibility Criteria

Inclusion Criteria

1. sex: female

2. ethnic origin: Caucasian

3. age: 18 - 55 years, inclusive

4. body-mass index (BMI): more than 19 kg/m² and less than 27 kg/m²

5. good state of health

6. non-smoker or an ex-smoker for a least 6 months

7. written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subject's participating in the study

Exclusion Criteria

Safety concerns

1. existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient

2. existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient

3. existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient

4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders

5. pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient

6. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations

7. subjects with severe allergies or multiple drug allergies

8. systolic blood pressure > 160 mmHg

9. diastolic blood pressure > 90 mmHg

10. heart rate < 45 and > 100 bpm

11. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator

12. positive anti-HIV-test, HBs-AG-test or anti-HCV-test

13. presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction and prodromal conditions (e.g. transient ischaemic attack, angina pectoris)), predisposition for venous or arterial thrombosis (e.g. APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency or other thrombogene coagulopathy, heart valve disorders or thrombogene cardiac dysrhythmias)

14. presence or history of liver tumours or known or suspected sex-hormone influenced malignancies (e.g. of the breasts or endometrium)

15. unclarified vaginal bleeding or amenorrhoe

16. subjects with fructose or galactose intolerance, deficiency of lactase, saccharase-isomaltase or malabsortion of glucose/galactose Lack of suitability for the trial

17. acute or chronic diseases which could affect absorption or metabolism

18. history of or current drug or alcohol dependence

19. regular intake of alcoholic food or beverages of ≥ 20 g per day

20. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient

21. regular intake of caffeine containing food or beverages of ≥ 500 mg per day

22. blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject

23. participation in a clinical trial during the last two months prior to individual enrolment of the subject

24. regular treatment with any systemically available medication (except usual replacement therapy with L-thyroxine)

25. subjects, who report a frequent occurrence of migraine attacks

26. use of hormonal preparations within 6 weeks (oral, transdermal, vaginal), 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 month) before pre-study examination

For female subjects with childbearing potential only:

27. positive pregnancy test at pre-study examination

28. pregnant or lactating women

29. female subjects who do not agree to apply adequate non-hormonal and highly effective contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000 Administrative reasons

30. subjects suspected or known not to follow instructions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pharbil Waltrop GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Donath, PhD

Role: PRINCIPAL_INVESTIGATOR

SocraTec R&D GmbH - Clinical Pharmacology Unit Mainzerhofplatz 14, 99084 Erfurt, Germany

Locations

SocraTec R&D

Erfurt, Thuringia, Germany

Countries

Germany

Other Identifiers

1229ed09ct

Identifier Type: -

Identifier Source: org_study_id