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Clinical Trial Details

Trial ID: L6974
Source ID: NCT01554293
Associated Drug: Matching Placebo
Title: Study Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Matching placebo|DRUG: PBL 1427 capsules
Outcome Measures: Primary: Number of subjects with adverse events, Safety and tolerability of PBL 1427 will be assessed after single ascending doses when administered alone on the basis of AEs, vital signs (BP, pulse rate, and body temperature), ECG, laboratory parameters and clinical assessment., Pre-dose and upto Day 5-9|Pharmacokinetics Variables (Cmax, tmax, AUC, t1/2, kel, CL/F & Vz/F), Pharmacokinetic parameters of single ascending doses of PBL 1427 : For each subject, blood will be collected at the following time points: pre-dose, 0.25, 0.50, 0.75 1, 1.5, 2, 3, 4, 6, 8, 10, 14, 16, 20, 24, 36 and 48 h post-dose., 48 hrs post dose | Secondary: Pharmacodynamics assessment (glucose, insulin, C-peptide, lactic acid), Pharmacodynamics will be assessed using markers like glucose, insulin, C-peptide, lactic acid and the exploratory markers plasma DPP-IV activity and plasma GLP-1 (Glucagon-like peptide I) levels, Pre-dose and upto 4 h post-dose|Exploratory markers (plasma DPP-IV activity and GLP-1 levels), Pharmacodynamics will be assessed using markers like glucose, insulin, C-peptide, lactic acid and the exploratory markers plasma DPP-IV activity and plasma GLP-1 (Glucagon-like peptide I) levels, Pre-dose and upto 48 h after dosing
Sponsor/Collaborators: Sponsor: Panacea Biotec Ltd
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2013-05-16
Locations: Fortis Clinical Research Ltd, Faridabad, Haryana, 121 002, India
URL: https://clinicaltrials.gov/show/NCT01554293