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NCT01600274
Characterisation of Relative Bioavailability and Assessment of Bioequivalence of a Newly Developed Ethinylestradiol/Dienogest IR Formulation in Comparison With a Marketed Reference Product (Valette®)
NA trial testing Dienogest-Ethinyl Estradiol (test product) in Focus: Bioequivalence in 20 participants. Completed in 1 February 2010.
1 February 2010
Quick facts
| Lead sponsor | Pharbil Waltrop GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2010 |
| Primary completion | 1 February 2010 |
| Estimated completion | 1 February 2010 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Dienogest-Ethinyl Estradiol (test product) — full drug profile →
- Dienogest-Ethinyl Estradiol (reference product) — full drug profile →
Conditions studied
- Focus: Bioequivalence — all drugs for Focus: Bioequivalence →
Sponsor
Pharbil Waltrop GmbH — full company profile →
Who can join
Adults 18 to 55, female only, with Focus: Bioequivalence. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cmax of EE and DNG after each treatment
Time frame: 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
Time frame: 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.
Sponsor's own description
* 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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01600274
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01600274 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharbil Waltrop GmbH
- Last refreshed: 4 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01600274.
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