Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets

NCT02980757 | Withdrawn Phase 1

• 1 other identifier: GLI-T020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15 healthy adult subjects under fasting conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.

Conditions

Comparative Bioavailability

Outcome Measures

Primary Outcomes (2)

• AUC(0-t) defined as The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.

  Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

• Cmax defined as Max. measured plasma concentration over the time span specified.

  Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

Secondary Outcomes (4)

• AUC(0-inf) defined as The area under the plasma concentration versus time curve from time (0) to infinity.

  Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

• AUCres defined as Residual area calculated as (AUC(0-inf) - AUC(0-t)) / AUC(0-inf).

  Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

• tmax defined as Time of the max. measured plasma concentration. If the max. value occurs at more than one time point, tmax is defined as the first time point with this value.

  Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

• t1/2: The elimination or terminal half-life will be calculated as 0.693/ Kel.

  Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours

Study Arms (3)

Gliclazide 120 mg MR Tablets Formula A

ACTIVE COMPARATOR

Single oral dose of one tablet containing 120 mg gliclazide

Drug: Gliclazide 120 mg MR Tablets Formula A

Gliclazide 120 mg MR Tablets Formula B

ACTIVE COMPARATOR

Single oral dose of one tablet containing 120 mg gliclazide

Drug: Gliclazide 120 mg MR Tablets Formula B

DIAMICRON MR® 60 mg x 2

ACTIVE COMPARATOR

Two x oral dose of one tablet containing 60 mg gliclazide

Drug: Gliclazide 120 mg MR Tablets

Interventions

Gliclazide 120 mg MR Tablets Formula A DRUG

Gliclazide 120 mg MR Tablets Formula A

Gliclazide 120 mg MR Tablets DRUG

Also known as: DIAMICRON MR® 60 mg

DIAMICRON MR® 60 mg x 2

Gliclazide 120 mg MR Tablets Formula B DRUG

Gliclazide 120 mg MR Tablets Formula B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 50 years, inclusive
• Body Mass Index (BMI) range is within 18.5 - 30.0 Kg/m2.
• Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.

You may not qualify if:

• Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
• Results of laboratory tests which are outside the normal range except for HbA1c test that are outside the reference range or Hb or RBC indices with deviation outside 5% of the reference range.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject is a heavy smoker (more than 10 cigarettes per day).
• Subject does not agree not to take any prescription or non-prescription drugs within the two weeks preceding the first study drug administration until the end of the study.
• Subject does not agree not to take any vitamins taken for nutritional purposes within two days before first study drug administration until the end of the study.
• Subject is on a special diet (for example subject is a vegetarian).
• Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, chocolate etc).
• Subject does not agree not to consume any beverages or food containing alcohol 48 hours prior to study drug administration until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, chocolate etc.) 24 hours prior to the study drug administration until the end of confinement period.
• Subject does not agree not to consume any beverages or food containing grapefruit 7 days prior to first study drug administration until donating the last sample in the study.
• Subject has a history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 80 days before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drugs administration.

Sponsors & Collaborators

• Disphar International B.V.: lead

Study Sites (1)

International Pharmaceutical Research Center

Amman, Jordan

Location

MeSH Terms

Interventions

Gliclazide

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• N. Najib, Pharm. Ph.D

  International Pharmaceutical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: December 2, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Last Updated: December 2, 2016

Record last verified: 2016-11

Locations

JO (1)