Bioavailability of BMS-original molecule
Phase 1
Completed
- Registration Number
- CTRI/2008/091/000304
- Lead Sponsor
- The Pharmaceutical Company Sponsoring This Study Is Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Signed Written Informed Consent
a) The signed informed consent form.
2) Target Population
a) Healthy subjects as determined by no clinically significant deviation from normal in medical history
3) Age and Sex
Women who are not of childbearing potential
Exclusion Criteria
1) Sex and Reproductive Status
a) Women of child bearing potential
2) Medical History and Concurrent Diseases
a) Any significant acute or chronic medical illness.
3) Physical and Laboratory Test Findings
a) Evidence of organ dysfunction or any clinically significant deviation from normal, as determined by the Investigator, in physical examination, vital signs, ECG or clinical laboratory determinations prior to dosing.
4) Allergies and Adverse Drug Reactions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioavailability of a high dose of BMS-pro-drug (of original molecule) tablet relative to half BID dosing of BMS-pro-drug (of original molecule) drug capsules.Timepoint: Four periods
- Secondary Outcome Measures
Name Time Method To assess the pharmacokinetics (PK) of BMS original molecule when BMS-pro-drug (of original molecule)tablet and BMS-original molecule tablet are administered.<br>? To assess the effect of a high fat meal (HFM) on the PKTimepoint: