Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet

NCT02217670 | Withdrawn Phase 1

• 1 other identifier: METF-GT016
• 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 a test formulation of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) relative to Glucophage 1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects under fed 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)

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

• Cmax

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

Secondary Outcomes (4)

• tmax

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

• AUC(0-inf)

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

• AUCres

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

• t1/2

  Before dosing (0.00 hour) and at the following times after the dose: 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours.

Other Outcomes (1)

• Number of participants with adverse events.

  24 hours

Study Arms (2)

Metformin (test)

EXPERIMENTAL

single oral dose of Metformin 1000 mg granules

Drug: Metformin 1000 mg granules

Metformin (reference)

ACTIVE COMPARATOR

Single dose of Glucophage 1000 mg film-coated tablet

Drug: Metformin 1000 mg film-coated tablets

Interventions

Metformin 1000 mg granules DRUG

Metformin (test)

Metformin 1000 mg film-coated tablets DRUG

Also known as: Glucophage

Metformin (reference)

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 or HbA1c test or liver or kidney function tests (Creatinine levels and ALP will be accepted if below reference range) that are outside the reference range or Hb or RBC indices (MCV, MCH, MCHC) 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 donating the last sample 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 donating the last sample 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/bioavailability 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

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: August 14, 2014
• First Posted: August 15, 2014
• Primary Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

JO (1)