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Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.

Information source: Chemi S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Enoxaparin Sodium is Administered to Healthy Volunteers

Intervention: Enoxaparin Sodium (Drug); Enoxaparin Sodium (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chemi S.p.A.

Official(s) and/or principal investigator(s):
Paolo Bettica, MD, Study Director, Affiliation: Italfarmaco S.p.A.

Summary

This will be an open-label, randomised, single-dose, 2-way crossover study to determine the comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s. c. (80 mg/0. 8mL) with that from the reference IMP, Clexane« s. c. (80 mg/0. 8mL), following single dose administration in healthy male and female subjects.

Clinical Details

Official title: Comparative, Randomized, Single-dose, 2-way Cross Over Bioavailability Study of Enoxaparin Sodium Chemi (80 mg/0.8mL) and Clexane« (80 mg/0.8mL) s.c. in Healthy Adult Subjects Under Fasting Conditions.

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: bioavailability of Enoxaparin Sodium Chemi and Clexane® s.c.

Secondary outcome: The secondary objective of this study is to assess safety and tolerability of Enoxaparin Sodium Chemi and Clexane®

Detailed description: Each subject will receive each treatment over two separate treatment periods under fasting conditions. Each dosing day for male subjects will be separated by a washout period of at least 7 days. The study will comprise of a pre-study screen (within 14 days of the first dose), followed by 2 Treatment Periods (1 and 2). During each treatment period, subjects will reside at Simbec from the evening before dosing (Day 1), until at least 36 h post dose

(evening of Day 2). On admission (Day - 1), subjects will provide a urine sample for a drugs

of abuse screen; this sample will also be tested to confirm a negative pregnancy result in female volunteers. A single dose of the randomised treatment will be given on the morning of Day 1 following an overnight fast and blood PK/PD samples collected from pre-dose up to 36 h post dose (14 samples). Safety will also be evaluated at specified times throughout the study. The post study visit will be conducted on Day 2 (36 h post-dose) of Treatment Period 2.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female volunteer between 18 and 55 years of age.

- Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / [Height (m)]2)

- Subject with no clinically significant abnormal serum biochemistry, haematology,

coagulation factors and urine examination values within 14 days of the first dose.

- Subject with no clinically significant abnormalities in 12-lead electrocardiogram

(ECG) and vital signs determined within 14 days of the first dose. Exclusion Criteria:

- Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low

molecular weight heparins, and/or pork products.

- Subject with a relevant history or presence of significant cardiovascular, pulmonary,

hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

- Female subject who is pregnant or lactating.

Locations and Contacts

Simbec Research Ltd, Merthyr Tydfil CF48 4DR, United Kingdom
Additional Information

Starting date: August 2014
Last updated: January 14, 2015

Page last updated: August 23, 2015

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