Clinical trial NCT04138888: A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
Official title: Single Dose Crossover Comparative Bioavailability Study of Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/25 mg Film-Coated Tablets in Healthy Adult Subjects / Fasting State
Conditions: Bioequivalence
Summary: This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two formulations (Olmesartan Medoxomil/ Hydrochlorothiazide (HCTZ), 40 mg/ 25 mg film-coated tablets (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Olmetec Plus® (Olmesartan Medoxomil/ Hydrochlorothiazide), 40 mg/25 mg film-coated tablets, (Manufacturer: Daiichi Sankyo Europe GmbH, Germany)) in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan and hydrochlorothiazide.
Interventions:
description: Olmesartan Medoxomil/Hydrochlorothiazide is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
name: Olmesartan Medoxomil/Hydrochlorothiazide 40 Mg/25 Mg film-coated tablets for oral use
other_name: The test product
type: Drug
description: Olmetec® Plus is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
name: Olmetec® Plus 40 Mg/25 Mg film-coated tablets for oral use
other_name: The reference product
type: Drug
Study arms:
design_group_description: 16 subjects assigned to the sequence AB will receive a single 40 mg/25 mg dose of the test product Olmesartan Medoxomil/ Hydrochlorothiazide (1 x 40 mg/ 25 mg tablet), marked as A in the sequence, in Period 1 and a single 40 mg/25 mg dose of the reference product Olmetec® Plus (1 x 40 mg/ 25 mg tablet), marked as B in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
design_group_title: Sequence AB
design_group_type: Other
design_group_description: 16 subjects assigned to the sequence BA will receive a single 40 mg/25 mg dose of the reference product Olmetec® Plus (1 x 40 mg/ 25 mg tablet), marked as B in the sequence, in Period 1 and a single 40 mg/25 mg dose of the test product Olmesartan Medoxomil/ Hydrochlorothiazide (1 x 40 mg/ 25 mg tablet), marked as A in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
design_group_title: Sequence BA
design_group_type: Other
Sponsor: Pharmtechnology, LLC
Collaborators: Altasciences Co., Inc.
Drug name mappings:
name: 奥美沙坦酯氢氯噻嗪
lang: CN
name: Hydrochlorothiazide/Olmesartan Medoxomil
lang: EN