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NCT04193852
Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product
Phase 1 trial testing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug in Bioequivalence in 10 participants. Completed in 25 November 2019.
12 November 2019
Quick facts
| Lead sponsor | Laboratorios Andromaco S.A. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 10 |
| Start date | 9 November 2019 |
| Primary completion | 12 November 2019 |
| Estimated completion | 25 November 2019 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug — full drug profile →
- Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Laboratorios Andromaco S.A. — full company profile →
Who can join
Adults 18 to 55, female only, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The Pilot study will be performed at a single site with 10 subjects. Participants will take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.
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 NCT04193852
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bioequivalence
Currently open trials in the same condition.
- NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting
Other Laboratorios Andromaco S.A. trials
Trials by the same sponsor.
- NCT05349396 — Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product · Phase 1 · completed
- NCT05332106 — Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product · Phase 1 · completed
- NCT05282940 — Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product · Phase 1 · completed
- NCT05250141 — Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product · Phase 1 · completed
- NCT05158192 — Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product · Phase 1 · completed
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 NCT04193852 (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 Laboratorios Andromaco S.A.
- Last refreshed: 10 December 2019
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/NCT04193852.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing