Focus: Bioequivalence
Conditions
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.
Interventions
DRUGDienogest-Ethinyl Estradiol (test product)
One tablet of Test
DRUGDienogest-Ethinyl Estradiol (reference product)
One tablet of Reference
Sponsors
Pharbil Waltrop GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Subjects cannot be included if they match any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a. |
| AUC0-tlast of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a. |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-∞ of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| Tmax of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| t1/2 of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| Clast of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| λ of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| MRT of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| Tlag of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| tlast of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
| AUCexpol% of EE and DNG after each treatment | PK blood sampling will be performed pre-dose (within 1.5 h prior to administration) as well as 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 36, 48 and 60 h p.a |
Countries
Germany
Outcome results
None listed