Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)

• Status: Not yet recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Unither Pharmaceuticals, France
• Collaborator: Accutest Research Laboratories (I) Pvt. Ltd.
• Treatments: Acetaminophen; Nefopam

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,