Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects

NCT04885660 | Completed Phase 1

• 1 other identifier: SR-BE-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The bioavailability of compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) developed by Sichuan shangrui biomedical Co., Ltd. was compared with that of reference compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) produced by Hungary Gedeon Richter Pharmaceutical Co., Ltd.The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax)

  Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation

  90 days

Study Arms (2)

Compound lisinopril tablets

EXPERIMENTAL

a single oral of Compound lisinopril tablets test formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)

Drug: compound lisinopril tablet

Compound lisinopril tablets(Lisonorm®)

ACTIVE COMPARATOR

a single oral of Compound lisinopril tablets reference formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)

Drug: compound lisinopril tablet(Lisonorm®)

Interventions

compound lisinopril tablet DRUG

The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)

Compound lisinopril tablets

compound lisinopril tablet(Lisonorm®) DRUG

The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)

Compound lisinopril tablets(Lisonorm®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
• Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination

You may not qualify if:

• History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Related Publications (1)

• Li T, Liu YP, Liu SQ, Shi P, Jiang X, Tao Y, Gao XM, Ma YP, Cao Y. Bioequivalence evaluation and food effect assessment of Lisinopril/amlodipine tablets in healthy Chinese subjects under fasting and fed conditions. BMC Pharmacol Toxicol. 2022 Jul 7;23(1):45. doi: 10.1186/s40360-022-00590-6.

  PMID: 35794660 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: October 12, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 20, 2019
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)