a clinical trial to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects

A randomized, double-blind, active-controlled, cross over, single dose study to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002485

Enrollment

Registered

2012-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: B09 EC: Single oral dose of B09 EC, 35 mg Duration:given only once Control Intervention1: Baclofen: Single oral dose of Baclofen, 20 mg Duration:given only once Control Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Availability of subject for the entire study period and willingness to adhere to protocol requirements. 2.Healthy male subjects, 18 to 45 years of age, subjects having weight at least 50Kg and the subjectâ??s body mass index (BMI) must be within 18.5 â?? 25.0 (Kg/m2) (inclusive). 3.Subjects who have no evidence of underlying disease during screening medical history and whose general examination is performed within 21 days prior to commencement of the study. 4.Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance. 5.Informed consent form given in written form

Exclusion criteria

Exclusion criteria: 1.History or presence of significant: 1.1Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or any related compounds etc. 1.2Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 1.3Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. 1.4Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day). 1.5History of difficulty in swallowing or coming for follow up. 1.6Clinically significant illness within 4 weeks before the start of the study 1.7Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study 1.8Positive result to HIV, HCV and HBs-Ag. 1.9Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study. 1.10Abnormal 12 lead ECG, X-ray. 2.Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study. 3.Participation in another clinical trial within the preceding 90 days of study starts. 4.Subjects who have: 4.1Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 4.2Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations ( 2-4mm Hg) at check-in may be acceptable at the discretion of the principal investigator. 4.3Pulse rate below 60/min. or above 100/min.

Design outcomes

Primary

Measure	Time frame
Adverse events, vital signs, clinical laboratory tests, ECGTimepoint: Baseline, Check-in of each period, Post study within 14 days	—

Secondary

Measure	Time frame
Pharmacokinetics parametersTimepoint: pre-dose, 0.167, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 20, 24, 36 hours after dose for each period	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Ltd.

Clinical.Trials@sparcmail.com912266455645

Outcome results