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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2016
• Main ID: NCT02217670
• Date of registration: 14/08/2014
• Prospective Registration: Yes
• Primary sponsor: Disphar International B.V.
• Public title: Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
• Date of first enrolment: November 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02217670
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Jordan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18 to 50 years, inclusive.

2. Body Mass Index (BMI) range is within 18.5 - 30.0 Kg/m2.

3. Subject does not have a known allergy to the drug under investigation or any of its
ingredients or any other related drugs.

Exclusion Criteria:

1. Medical demographics performed not longer than two weeks before the initiation of the
clinical study with significant deviations from the normal ranges.

2. 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.

3. Acute infection within one week preceding first study drug administration.

4. History of drug or alcohol abuse.

5. Subject is a heavy smoker (more than 10 cigarettes per day).

6. 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.

7. 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.

8. Subject is on a special diet (for example subject is a vegetarian).

9. Subject consumes large quantities of alcohol or beverages containing methylxanthines
e.g. caffeine (coffee, tea, cola, chocolate etc).

10. 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.

11. 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.

12. 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.

13. Subject has a history of severe diseases which have direct impact on the study.

14. Participation in a bioequivalence/bioavailability study or in a clinical study within
the last 80 days before first study drug administration.

15. Subject intends to be hospitalized within 3 months after first study drugs
administration.

16. Subjects who donated blood or its derivatives in the past 3 months or who through
completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml
in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.

17. The female subject is pregnant or lactating.

18. Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis,
pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired
hepatic function), cardiovascular disorder, neurological disease such as epilepsy,
haematological disorders, type I diabetes or diabetic ketoacidosis, lactic acidiosis,
Vitamin B12 deficiency, psychiatric, dermatologic, immunological disorders or
surgery.

19. Subject does not agree not to engage in strenuous exercise at least one day prior to
study drug administration.

20. Subject having at screening examination a pulse outside the normal range of (60-100
beat per minute) or a body temperature outside the normal range of (36.4-37.7 ?C) or
a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting
blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.

21. Subject has history of difficulties in swallowing or any gastrointestinal disease
which could affect the drug absorption.

22. Subject undergoing radiologic studies involving intravascular administration of
iodinated contrast materials (for example, intravenous urogram, intravenous
cholangiography, angiography, and computed tomography (CT) scans with intravascular
contrast materials).

23. Fasting blood sugar at screening is less than 70 mg/dl.

24. Subject has diabetes mellitus.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Comparative Bioavailability

Intervention(s)

Drug: Metformin 1000 mg film-coated tablets

Drug: Metformin 1000 mg granules

Primary Outcome(s)

Cmax [Time Frame: 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-t) [Time Frame: 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 Outcome(s)

t1/2 [Time Frame: 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) [Time Frame: 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 [Time Frame: 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.]

tmax [Time Frame: 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 ID(s)

METF-GT016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors