BERLIN-CHEMIE AG

ACTIVE

147 Tsarigradsko Shose, Sofia, Stolichna, Bulgariawww.berlin-chemie.deSubsidiary

Clinical Trials

7 active

Approvals

Total approvals

Agencies

Regulatory bodies

Founded

N/A

Overview

Trial Phase Distribution

Phase

Trials

Phase 1

22.2%

Phase 4

11.1%

Trial Status Distribution

Active, not recruiting

77.8%

Completed

22.2%

Clinical Trials

Trials sponsored by this organization (9)

A comparative bioavailability of reformulated ibuprofen 2% and 4% oral suspensions (Berlin Chemie AG) and reference ibuprofen (Nurofen®) 200 mg/5 ml oral suspension in healthy male and female adult subjects under fasting conditions: an open-label, randomized, single-dose, three-period, three-treatment, three-sequence crossover study

Phase 1

Active, not recruiting

interventional

Jun 202375 participants

A prospective non-interventional study to assess quality of life and COPDsymptoms in patients with COPD on LAMA/LABA/ICS triple therapy withElebrato® Ellipta®

Completed

observational

May 2023931 participants

The purpose of this study is to investigate the efficacy and safety of the ibuprofen suspension, developed by Berlin-Chemie AG for oral administration (20 mg/ml and 40 mg/ml) compared to Nurofen® in reducing fever and pain in children at the age of 3-9 years old with uncomplicated acute otitis media.

Active, not recruiting

Dec 2015135 participants

Effects of nebivolol on the cardiovascular functions, thermoregulation and blood flow during real and simulated conditions of microgravity - MISSION Medicine In Space Study - Investigation Of Nebivolol

Phase 1

Active, not recruiting

Jan 2008

EBIVOLOL OR METOPROLOL IN ARTERIAL OCCLUSIVE DISEASEA DOUBLE-BLIND, RANDOMISED CLINICALDeutscher Titel: Nebivolol im Vergleich zu Metoprolol bei peripherer arterieller VerschlusskrankheitEine randomisierte, doppel-blinde klinische Studie - NORMA

Active, not recruiting

Oct 2006160 participants

Effects of Frovatriptan as Prophylactic Treatment of Cluster Headache, a Multi-Center, Placebo Controlled, Randomized, Double-Blind Prospective Phase III Parallel-Group Trial Comparing Frovatriptan with Placebo

Active, not recruiting

Aug 200680 participants

RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002

Active, not recruiting

Sep 200520 participants

RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003

Active, not recruiting

May 200520 participants

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Approvals

Approvals by Agency

NMPA

National Medical Products Administration

Approvals

EMA

European Medicines Agency

Approvals

PHILIPPINES

Philippines FDA

Approvals

SFDA

Saudi Food and Drug Authority

Approvals

NPRA

National Pharmaceutical Regulatory Agency

Approvals

CIMA_AEMPS

Spanish Agency for Medicines and Medical Devices

Approvals

Recent Approvals

Bilaxten 2.5 mg/ml Oral Solution

NPRA

2025-12-25

Bilaxten 2.5 mg/ml Oral Solution

DEBROMU 40MG F.C.TABLET

SFDA

2025-07-18

Levothyroxine Sodium Tablets

NMPA

2024-12-13

Levothyroxine Sodium Tablets

Dapoxetine Hydrochloride Tablet

NMPA

2024-05-31

News

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