Clinical Trials Logo

Clinical Trial Summary

This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies.


Clinical Trial Description

Twenty healthy subjects will be allocated 4:1 to either the crossover study groups (16 subjects) or to the 0.25 mg tablet single dose treatment (4 subjects). Subjects allocated to the crossover study groups will be randomized 1:1 to 0.5 mg tablet/capsule (8 subjects) or 1.0 mg tablet/capsule (8 subjects). Within the crossover study groups, subjects will be further randomized to receive a single dose of KBP-5074 (0.5 mg or 1.0 mg) in either capsule or tablet formulation in a 2-period crossover design with a 2-week washout period. The study duration for subjects in the crossover study groups will be approximately 7 weeks, which includes a 3-week screening period, and the 2 crossover single dose periods, which will be followed by a 2-week washout/follow-up period, respectively. Subjects allocated to the 0.25 mg dose cohort (n=4) will receive a single dose of 0.25 mg in tablet formulation only. The 0.25 mg tablet cohort will provide additional data for the evaluation of dose exposure for the tablet formulation. The study duration for the single dose arm will be 5 weeks, which includes a 3-week screening period, and the single dose which will be followed by a 2 week washout period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03340753
Study type Interventional
Source KBP Biosciences
Contact
Status Completed
Phase Phase 1
Start date October 26, 2017
Completion date December 19, 2017

See also
  Status Clinical Trial Phase
Completed NCT03705533 - Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State Phase 1
Completed NCT04938856 - Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions Phase 1
Completed NCT03646331 - Bioequivalence of Imeglimin Tablet Formulations Phase 1
Completed NCT04564456 - A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05197517 - Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition Phase 1
Completed NCT03702894 - Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions Phase 1
Completed NCT03018015 - Ibuprofen Bioavailability Trial With Oral Single Dose Administration. Phase 1
Withdrawn NCT02894515 - Bioequivalence Study of Idalopirdine in Healthy Subjects Phase 1
Completed NCT02206295 - Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg Phase 1
Completed NCT01331993 - A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation Phase 1
Completed NCT01260805 - A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. Phase 1
Recruiting NCT06066112 - Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body Phase 1
Completed NCT05477810 - Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions Early Phase 1
Completed NCT04546256 - A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05083325 - Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Phase 1
Completed NCT05061901 - Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions Phase 1
Recruiting NCT04138888 - A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Completed NCT06124560 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. Phase 1
Completed NCT04230070 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Phase 1