A study to investigate the analgesic effects of buprenorphine and milnacipram in healthy volunteers.

Completed

• Conditions: pain (neuropathic and acute); neuropathic pain; nociceptive pain

• Registration Number: NL-OMON37273
• Lead Sponsor: Dr. Reddy's Laboratories Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure.
2. Caucasian (white) males aged between 18 and 45 years (inclusive) at screening.
3. Body mass index (BMI) between 18 and 30 kg/m2 (exclusive) at screening.
4. No clinically significant findings on the physical examination at screening.
5. Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study.
6. Systolic blood pressure (SBP) between 100 and 140 mmHg (inclusive).
7. Diastolic blood pressure (DBP) between 45 and 90 mmHg (inclusive).
8. Heart rate (HR) between 45 and 100 b.p.m. (inclusive).
9. Haematology and clinical chemistry results within normal range (to a clinically relevant extent at screening).
10. Negative results for urine drug tests at screening.
11. 12-lead electrocardiogram (ECG) normal or to have no clinically significant alterations.

Exclusion Criteria

1. Known hypersensitivity to buprenorphine and/or milnacipran.
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 within 7 days prior to screening.
6. Smoking within 3 months prior to screening and inability to refrain from smoking during the course of study. 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. Loss of 250 mL or more of blood within 3 months prior to screening.
9. Positive results from the hepatitis serology at screening.
10. Positive results from the HIV serology at screening.
11. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
12. Legal incapacity or limited legal capacity at screening.;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. Any vital signs or laboratory values which are out of the normal range for the age group should be excluded unless the study physician and/or the principal investigator deems not to be clinically significant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified