12 completed, 1 active not recruiting, 1 unknown. 7 Phase 1, 5 Not applicable, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 6, Active not recruiting 1 |
| Not applicable | 5 | Completed 5 |
| Phase 3 | 1 | Completed 1 |
| Phase 4 | 1 | Unknown 1 |
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| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions SKI-O-703 API in Capsules, SKI-O-703 Formulated Granules in Capsules - Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP) | Phase 1 | Active not recruiting | Oscotec Inc. | 48 | 2026-07-10 | 2026-09-01 |
| Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 500 mg Tablets Under Fed Conditions. Synjardy 5/850 mg tablet, Reference, Empagliflozin/metformin 12.5/500 mg test - Bioequivalence Study in Healthy Subjects | Not applicable | Completed | ADIUM | 42 | 2025-09-10 | 2026-06-10 |
| Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet - Bioequivalence Study in Healthy Subjects, PK/PD | Phase 3 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2025-07-01 | 2026-03-06 |
| Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations Test Product (Glimcoza), Reference (R) Twymeeg® - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | Aya Mohammed Abdel Magid Abdel Hamid | 29 | 2025-03-09 | 2025-08-24 |
| Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 5 mg / 850 mg Tablets Under Fed Conditions. Test. Empagliflozin/metformin 5/850 mg, Synjardy 5/850 mg tablet, Reference - Bioequivalence Study in Healthy Subjects | Not applicable | Completed | ADIUM | 42 | 2025-02-17 | 2026-06-10 |
| Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 850 mg Tablets Under Fed Conditions. Empagliflozin/metformin 12.5/850 mg tablet (test), Synjardy 12.5/850 mg tablet (Reference) - Bioequivalence Study in Healthy Subjects | Not applicable | Completed | ADIUM | 42 | 2025-02-10 | 2026-06-10 |
| Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets Under Fed Conditions. Synjardy 12.5/1000 mg tablet, Empagliflozin/metformin 12.5/1000 mg - Bioequivalence Study in Healthy Subjects | Not applicable | Completed | ADIUM | 42 | 2025-02-05 | 2026-06-10 |
| Pharmacokinetics and Bioequivalence Study of Budesonide Inhalation Aerosol in Humans Budiair® 200ug/puff inhalation aerosol, budesonide 200ug/puff inhalation aerosol - Bioequivalence Study in Healthy Subjects | Not applicable | Completed | Lunan Better Pharmaceutical Co., LTD. | 32 | 2024-12-30 | 2025-04-11 |
| Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions Parecoxib - Post-operative Pain, Bioequivalence Study in Healthy Subjects | Phase 4 | Unknown | Yung Shin Pharm. Ind. Co., Ltd. | 14 | 2024-10-01 | 2024-09-20 |
| Brivaracetam Bioequivalence Assessment Briveka ® 100 mg, Briviact® 100 mg - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | Zodiac Produtos Farmaceuticos S.A. | 28 | 2024-08-09 | 2026-09-02 |
| Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations Test Product (Vocarzine), Reference (R) Reagila ® - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | Aya Mohammed Abdel Magid Abdel Hamid | 29 | 2024-08-03 | 2025-08-17 |
| Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations Lepsiramp, 0.5 Mg/mL Oral Suspension, Fycompa, 0.5 Mg/mL Oral Suspension - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | Aya Mohammed Abdel Magid Abdel Hamid | 26 | 2024-03-07 | 2025-08-20 |
| Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment Rivastigmine TDS 9,5 mg/24 h, Exelon® 9.5 mg/24 h - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | Zodiac Produtos Farmaceuticos S.A. | 68 | 2023-05-12 | 2026-03-11 |
| Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment), 5 mg Flupentixol film-coated tablet (test treatment) - Bioequivalence Study in Healthy Subjects | Phase 1 | Completed | H. Lundbeck A/S | 84 | 2016-01-01 | 2016-07-26 |
Arthritis, Rheumatoid (1) · Diabetes Mellitus (1) · Epilepsy (1) · Pain, Postoperative (1) · Purpura, Thrombocytopenic, Idiopathic (1) · Schizophrenia (1)
Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2) · Signs and Symptoms (2) · Arthritis (1) · Autoimmune Diseases (1) · Blood Coagulation Disorders (1) · Blood Platelet Disorders (1) · Brain Diseases (1) · Central Nervous System Diseases (1) · Connective Tissue Diseases (1) · Cytopenia (1) · Endocrine System Diseases (1) · Glucose Metabolism Disorders (1) · Hematologic Diseases (1) · Hemic and Lymphatic Diseases (1)
Tablets (5) · Metformin (4) · empagliflozin (3) · Budesonide (1) · Capsules (1) · Flupenthixol (1) · Rivastigmine (1) · Spironolactone (1) · Suspensions (1) · Torsemide (1) · brivaracetam (1) · cariprazine (1) · parecoxib (1) · perampanel (1)
ADIUM (4) · Aya Mohammed Abdel Magid Abdel Hamid (3) · Zodiac Produtos Farmaceuticos S.A. (2) · H. Lundbeck A/S (1) · Lunan Better Pharmaceutical Co., LTD. (1) · Oscotec Inc. (1) · Sarfez Pharmaceuticals, Inc. (1) · Yung Shin Pharm. Ind. Co., Ltd. (1)
Mexico (4) · Egypt (3) · Brazil (2) · China (1) · Russia (1) · South Korea (1) · Taiwan (1) · United States (1)
Kamal A. Badr, PhD (2) · Kai Huang, Dr (1) · Kamal A. Badr, Ph.D. (1) · Salim Shah, PhD, JD (1)
PMID 42653697, PMID 41249688, PMID 41291275, PMID 41318994, PMID 41689599