A study of the effect of buprenorphine in combination with milnacipran in a pain model in healthy volunteers.

Conditions: Pain therapeutics, neuropathic pain, nociceptive pain, synergism between opioids and TCA.
MedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 10018065 - General disorders and administration site conditions
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-002302-43-NL

Lead Sponsor: Dr. Reddy's Laboratories Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

1.Caucasian (white) males aged between 18 and 45 years (inclusive) at screening with no clinically significant findings on the physical examination.
2.Signed informed consent prior to any study-mandated procedure.
3.Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening.
4.Systolic blood pressure (SBP) 100–140 mmHg, diastolic blood pressure (DBP) 60–90 mmHg, and heart rate (HR) 45–90 b.p.m. (all inclusive).
5.12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
6.Haematology and clinical chemistry results within normal range to a clinically relevant extent at screening.
7.Negative results from urine drug screen at screening.
8.Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

All clinical judgments will be done by the study physician and he or she will decide eligibility of the subjects based on individual evaluation for each case.

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to any excipients of the drug formulations.
2.Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John’s Wort), within 7 days prior to screening.
3.Treatment with another investigational drug within 3 months prior to screening.
4.History or clinical evidence of alcoholism or drug abuse.
5.Treatment with or consumption of inducers or inhibitors of CYP3A4 (e.g. grapefruit (juice), star fruit) or CYP2C8.
6.Excessive caffeine consumption, defined as = 800 mg per day at screening.
7.History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
8.Smoking within 3 months prior to screening and inability to refrain from smoking during the course of study.
9.Loss of 250 mL or more of blood within 3 months prior to screening.
10.Positive results from the hepatitis serology (except in the case of VHB for vaccinated subjects) at screening.
11.Positive results from the HIV serology at screening.
12.Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
13.Legal incapacity or limited legal capacity at screening.