Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers

NCT02969252 | Completed Phase 1

• 1 other identifier: CB-01-11/27
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Cmax

  Cmax,0-24 h

  Day 1

• Cmax

  Cmax,0-6

  Day 1

• tmax

  tmax,0-24

  Day 1

• tmax

  tmax,0-6

  Day 1

• AUC

  AUC 0-24

  Day 1

• AUC

  AUC 0-6

  Day 1

Study Arms (1)

Open label

OTHER

Single and multiple dose, open label, pharmacokinetics and safety study

Drug: Rifamycin SV-MMX® 600

Interventions

Rifamycin SV-MMX® 600 DRUG

Open label

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex and Age: men and women, 18-55 year old inclusive
• Body Mass Index: 18.5-30 kgm2 inclusive
• Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
• Fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year.
• For all female subjects, pregnancy test result had to be negative at screening and Day -1

You may not qualify if:

• ECG 12-leads (supine position): clinically significant abnormalities
• Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
• Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
• Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
• Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
• Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
• Blood donation: blood donations for 3 months before this study
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than 1 drink a day for females and more than 2 drinks a day for males, defined according to the USDA Dietary Guidelines 2010), caffeine (more than 5 cups coffee/tea/day) or tobacco abuse (10 cigarettes a day)
• Abuse drug test: positive result at the drug test at screening or Day-1
• Alcohol test: positive alcohol breath test at Day -1
• Diet: abnormal diets (less than1600 or more than 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
• Pregnancy (females only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

Related Publications (1)

• Di Stefano AFD, Radicioni MM, Vaccani A, Mazzetti A, Longo LM, Moro L. Pharmacokinetics and Safety of Rifamycin SV after Single and Multiple Doses of MMX(R) Modified Release Tablets in Healthy Male and Female Volunteers. Antibiotics (Basel). 2021 Feb 6;10(2):167. doi: 10.3390/antibiotics10020167.

  PMID: 33562091 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 21, 2016
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Last Updated: January 26, 2018

Record last verified: 2018-01