Clinical Pharmacology Clinical Trial
Official title:
Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02286518 -
TAK-114 Single- and Multiple-Dose Phase 1 Study
|
Phase 1 | |
| Completed |
NCT01473108 -
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
|
Phase 1 | |
| Completed |
NCT03424135 -
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
|
Phase 1 | |
| Completed |
NCT05437094 -
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
|
Phase 1 | |
| Completed |
NCT02276274 -
Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
|
Phase 3 | |
| Completed |
NCT03074058 -
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
|
Phase 1 | |
| Completed |
NCT04511611 -
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects
|
Phase 1 | |
| Completed |
NCT04511637 -
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects
|
Phase 1 | |
| Completed |
NCT02113020 -
A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04364464 -
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
|
Phase 1 | |
| Completed |
NCT06126861 -
The Mass Balance Study of LP-168 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03517943 -
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT03136666 -
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
|
Phase 1 | |
| Completed |
NCT03517930 -
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT04366622 -
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
|
Phase 1 |