healthy volunteers (symptomatic treatment of pain)
Conditions
Interventions
Trade Name: TRAMIUM®
Pharmaceutical Form: Capsule
INN or Proposed INN: tramadol
Other descriptive name: TRAMADOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males or females aged 18-65 years inclusive. 2) Healthy as determined by the medical history and the physical examination. 3) Clinical laboratory tests results at screening within the reference ranges or considered as non-clinically significant by the Investigator. 4) Able and willing to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Female subjects who are pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception (IUD, OCS, spermicide + condom, vaginal ring, hormonal patch, implant). 2) Presence of respiratory, gastrointestinal, renal, hepatic, haematological or cardiovascular disease. 3) History and/or presence of epileptic seizures. 4) Known hypersensitivity to study treatments or to any of the excipients. 5) History of alcoholism (considered as above 21 beverages per week: one alcoholic beverage is defined as 30 ml distilled spirits, 120 ml wine, or 330 ml beer) or/and drug addiction. 6) Dysphagia or difficulty swallowing tablets or capsules. 7) Use of any prohibited medication as detailed in the concomitant medication section 6.7. 8) Use of any investigational drug or participation in any clinical trial within 1 month or within 5 times half-life of the relevant drug (whichever is longer) before the study drug administration (Period 1). 9) Donation or receipt of any blood or blood products within 3 months before the study drug administration (Period 1). 10) Subjects who were unlikely to co-operate with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of paracetamol on the tramadol safety profile.;Secondary Objective: none. ;Primary end point(s): No efficacy endpoints in this study. Safety variables: Adverse events, Vital signs (SBP, DBP, PR), Subject’s global assessment of treatment tolerability (5-point rating scale), Withdrawal due to adverse events;Timepoint(s) of evaluation of this end point: The time points of evaluation are described in section 4.2.5 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none. ;Timepoint(s) of evaluation of this end point: none. | — |
Countries
Bulgaria
Contacts
Public ContactClinical Department
Laboratoires SMB S.A.
Outcome results
None listed