Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
Launched by UNITHER PHARMACEUTICALS, FRANCE · Nov 10, 2021
Trial Information
Current as of May 20, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and non-pregnant female human subjects, age 18 - 45 years.
- • Body Mass Index between 18.5-30 Kg / m2 .
- • Subjects with normal findings .
- • Willingness to follow the protocol requirements
- Exclusion Criteria:
- • Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
- • Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- • Subjects with a history of convulsive disorders.
- • Subject with a moderate or severe renal impairment
- • History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- • Female subjects not confirming to using birth control measures,
About Unither Pharmaceuticals, France
Unither Pharmaceuticals, based in France, is a leading global contract development and manufacturing organization (CDMO) specializing in innovative drug delivery systems and formulation development. With a strong emphasis on quality and regulatory compliance, Unither Pharmaceuticals partners with pharmaceutical and biotechnology companies to provide high-quality, tailored solutions across a wide range of therapeutic areas. The company is dedicated to advancing healthcare by leveraging its expertise in the development of complex dosage forms, including sterile and non-sterile products, while maintaining a commitment to sustainability and patient-centric approaches in its clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Navi Mumbai, , India
Patients applied
Trial Officials
Pramila Yadav, MS
Principal Investigator
Accutest Research Laboratories
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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