The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.
This study will be a randomized, double blind, placebo controlled study and is divided into four plans: 1. Plan I: Single Ascending Dose (SAD) Study 2. Plan II: Multiple Ascending Dose (MAD)Study 3. Plan III: Gender Effect study 4. Plan IV: Food Effect study First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Clinical R&D, Zydus Research Center, Cadila Healthcare Limited, NH No.8, Moraiya
Ahmedabad, Gujarat, India
Safety and tolerability
Safety and tolerability for- * Plan I, Plan III and Plan IV \[Time frame: up to Day 8\] * Plan II \[Time frame: upto Day 14\] Frequency of adverse events will be assessed at each dose level.
Time frame: Upto 14 Days
Pharmacokinetics
Pharmacokinetics after oral administration of ZYGK1 in * Plan I, III and IV: \[Time frame: 0.25 - 168 hrs post drug administration\] * Plan II: \[Time frame:Day 1: 0.25 - 12 hours, Day 2-6: 0, 2, 4 Hours, Day: 0.25-168 hours post drug administration\] Effects of food on the pharmacokinetics will be assessed in healthy subjects.
Time frame: 7 Days
Pharmacodynamics
Plasma glucose, serum insulin, C-peptide and glucagoan estimate - * Plane I and Plan III \[Time frame: Day 0 and Day 1: upto 4 hours post oral glucose 75 grams\] * Plan II \[Time frame: Day 0, Day 1 and Day 7: upto 4 hours post oral glucose 75 grams\] * Plan IV: \[Time frame: Period 2: Day 0 and Day 1: upto 4 hours post meal\]
Time frame: 7 Days
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