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NCT03657550

Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

Completed Phase 1 Last updated 16 September 2021
What this trial tests

Phase 1 trial testing Levamlodipine, Amlodipine in Hypertension in 36 participants. Completed in 6 September 2018.

Timeline
31 May 2018
Primary endpoint
6 September 2018
6 September 2018

Quick facts

Lead sponsorConjupro Biotherapeutics, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment36
Start date31 May 2018
Primary completion6 September 2018
Estimated completion6 September 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Conjupro Biotherapeutics, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Conjupro Biotherapeutics, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03657550.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing