Bioequivalence Clinical Trial
Official title:
A Phase I, Open-Label, Randomized, 2-Treatment, 2-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule
This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.
Eligible healthy participants will be randomized to receive either treatment sequence 1 (AB) or treatment sequence 2 (BA), as follows: - Treatment A: Acalabrutinib tablet, 100 mg, fasted state - Treatment B: Acalabrutinib capsule, 100 mg, fasted state Participants will receive fixed single doses of acalabrutinib on 2 occasions, under fasted conditions. The study will comprise: - Visit 1: A screening period of up to 28 days before first dosing. - Visit 2: Two treatment periods: - Participants will be admitted to the study center on Day -2 of Treatment Period 1 to confirm eligibility before first dosing. Eligibility criteria will be reconfirmed on Day -1 of each treatment period. - On Day 1 of Treatment Periods 1 and 2, participants will be administered the assigned treatment (A or B) as randomized, followed by a protocol defined washout period between Treatment Periods 1 and 2. - Visit 3: A Follow-up Visit/Early Termination Visit at 7 to 10 days after last administration of study drug. Each participant will be involved in the study for approximately 6 weeks. ;
| 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 | |
| Withdrawn |
NCT02894515 -
Bioequivalence Study of Idalopirdine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03018015 -
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|
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 |
NCT03340753 -
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
|
Phase 1 |