Overview

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,