20 completed. 18 Phase 1, 2 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 18 |
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product Eszopiclone 3mg Test Drug T-1 Coated Tablets, Eszopiclone 3mg Test Drug T-2 Coated Tablets, Eszopiclone 3mg Reference Product Coated Tablets - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 28 | 2022-04-11 | 2022-04-27 |
| Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet, Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 10 | 2022-03-12 | 2022-04-18 |
| Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Microgynon CD - Therapeutic Equivalency | Phase 1 | Completed | Laboratorios Andromaco S.A. | 36 | 2022-02-26 | 2022-06-02 |
| Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product Levodopa 250mg and Carbidopa 25mg Test Drug tablet, Levodopa 250mg and Carbidopa 25mg Referent Product tablet - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 44 | 2022-02-14 | 2022-03-08 |
| Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product Diosmin/Hesperidin (90/10) 500 mg Test Drug, Diosmin/Hesperidin (90/10) 500 mg Reference Product - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 12 | 2021-11-04 | 2022-02-14 |
| Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Oseltamivir 75mg Test Drug capsules, Oseltamivir 75mg capsules Reference Product capsules - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 36 | 2021-10-08 | 2021-10-28 |
| Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions Duloxetine 60mg Test Drug Enteric Coated Granules, Duloxetine 60mg Reference Product Enteric Coated Granules - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 36 | 2021-02-27 | 2021-04-15 |
| Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions Duloxetine 60mg Test Drug Enteric Coated Granules, Duloxetine 60mg Reference Product Enteric Coated Granules - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 36 | 2021-01-23 | 2021-04-15 |
| Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets, Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 38 | 2021-01-16 | 2021-04-15 |
| Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product, Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 10 | 2020-11-21 | 2021-02-10 |
| Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 30 | 2020-10-24 | 2021-02-10 |
| Bioavailability of Clotiazepam 5 mg With Regards to Reference Product Clotiazepam 5 mg Test Product Coated Tablets, Clotiazepam 5 mg Reference Product Coated Tablets - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 26 | 2020-03-11 | 2020-06-19 |
| Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product Desogestrel 0.075 MG - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 30 | 2020-01-11 | 2020-06-09 |
| Bioavailability of Dienogest 2.0 mg With Regards to Reference Product Dienogest 2.0 mg Test Drug, Dienogest 2.0 mg Reference Product - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 30 | 2019-12-07 | 2020-01-18 |
| Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product - Bioequivalence | Phase 1 | Completed | Laboratorios Andromaco S.A. | 10 | 2019-11-09 | 2019-12-10 |
| Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA) Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg, Testosterone - Pharmacokinetics, Hormone Deficiency | Phase 1 | Completed | Laboratorios Andromaco S.A. | 46 | 2015-11-20 | 2019-05-30 |
| Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve DHEA, Another Androgenic Agent (VRaA), Fixed combination of 2 androgenic agents (VR2A) - Healthy Women, Infertility, Female | Phase 1 | Completed | Laboratorios Andromaco S.A. | 94 | 2014-07-15 | 2019-05-29 |
| Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea Meloxicam, Diclofenac Potassium, Placebo Oral - Dysmenorrhea | Phase 2 / Phase 3 | Completed | Laboratorios Andromaco S.A. | 68 | 2014-06-27 | 2019-05-03 |
| Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, Progesterone Cervical Pessary 7.7 g - Preterm Birth | Phase 2 | Completed | Grünenthal GmbH | 271 | 2013-09-02 | 2018-10-23 |
| Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women Meloxicam 2.4 g, Meloxicam 3.0 g - Contraception, Bleeding Pattern | Phase 1 | Completed | Laboratorios Andromaco S.A. | 13 | 2013-01-15 | 2019-04-30 |
Dysmenorrhea (1) · Infertility, Female (1) · Premature Birth (1)
Drug Evaluation (9) · Patents as Topic (6) · Ethinyl Estradiol (5) · Levonorgestrel (3) · dienogest (3) · Dehydroepiandrosterone (2) · Duloxetine Hydrochloride (2) · Meloxicam (2) · Capsules (1) · Carbidopa (1) · Desogestrel (1) · Diclofenac (1) · Diosmin (1) · Estradiol (1) · Eszopiclone (1)
Chile (14) · India (6)
R. Amirtha, MD (1)