9 completed, 1 unknown. 10 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 9, Unknown 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 |
|---|---|---|---|---|---|---|
| Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid Efavirenz, tenofovir /emtricitabine, tenofovir/lamivudine - HIV | Phase 1 | Unknown | St Stephens Aids Trust | 35 | 2016-11-21 | 2017-06-21 |
| Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects M834, US-Sourced Orencia®, EU-Sourced Orencia® - Healthy Volunteers | Phase 1 | Completed | Momenta Pharmaceuticals, Inc. | 243 | 2016-10-01 | 2017-10-24 |
| Thorough QT (TQT) Study of TD-4208 in Healthy Subjects TD-4208 175 mcg, TD-4208 700 mcg, Placebo for TD-4208 - Cardiac Repolarization in Healthy Subjects | Phase 1 | Completed | Mylan Inc. | 48 | 2016-05-01 | 2022-02-24 |
| Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment TD-4208 - Renal Impairment | Phase 1 | Completed | Mylan Inc. | 16 | 2015-12-01 | 2022-02-24 |
| Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment TD-4208 - Hepatic Impairment | Phase 1 | Completed | Mylan Inc. | 16 | 2015-11-01 | 2022-02-24 |
| SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women Efavirenz, tenofovir /emtricitabine, tenofovir/lamivudine - HIV | Phase 1 | Completed | St Stephens Aids Trust | 26 | 2015-08-01 | 2017-10-20 |
| TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects TD-4208 - Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | Mylan Inc. | 9 | 2015-06-01 | 2022-02-24 |
| Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers MYL-1402O, US marketed Avastin(R), EU marketed Avastin(R) - Healthy | Phase 1 | Completed | Mylan Inc. | 111 | 2015-04-01 | 2022-03-25 |
| Adalimumab PK Bioequivalence Study to EU and US Sourced Humira BMO-2, EU-Humira, US-Humira - Healthy Volunteers | Phase 1 | Completed | Mylan Inc. | 270 | 2014-12-01 | 2022-03-11 |
| Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta MYL-1401H, EU-Neulasta, US-Neulasta - Healthy Volunteers | Phase 1 | Completed | Mylan Inc. | 218 | 2014-09-01 | 2022-02-14 |
Hepatitis (1) · Liver Cirrhosis (1) · Pulmonary Disease, Chronic Obstructive (1) · Renal Insufficiency (1)
revefenacin (4) · Emtricitabine (2) · Lamivudine (2) · Tenofovir (2) · efavirenz (2) · lamivudine, zidovudine drug combination (2) · Abatacept (1) · Adalimumab (1) · Bevacizumab (1) · Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (1) · Granulocyte Colony-Stimulating Factor (1) · Isoniazid (1) · MYL-1401H (1) · Moxifloxacin (1) · Rifampin (1)
United States (4) · United Kingdom (3) · Netherlands (2) · Belgium (1) · Uganda (1)
Fausto Berti (2) · Marta Boffito, MBBS,MD,PhD (2) · Candida Fratazzi, MD (1) · James Bush, MBChB, PhD, MRCS(Ed), MFPM (1) · Magdalena Petkova, MD (1) · Matthew A. Hummel, PhD (1) · Mohammed Lamorde, MBBS (1) · Mohammed Lamorde, MBBS,MRCP,PhD (1) · Renger Tiessen, MD, PhD (1)
PMID 31632000, PMID 30084943, PMID 33866430
2014 (3)