Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers

NCT02196662 | Completed Phase 1 DMC

• 1 other identifier: 110200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the rate and extent of absorption of mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x 400 mg delayed-release capsule under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve in plasma of IBD98-M

  Day 5

Study Arms (3)

Treatment A

EXPERIMENTAL

IBD98-M: mesalamine-sodium hyaluronate 200mg-28.75mg X2

Drug: IBD98-M:

Treatment B

EXPERIMENTAL

IBD98-M without HA: Mesalamine 200mg X2

Drug: IBD98-M without HA

Treatment C

EXPERIMENTAL

Delzicol 200 mg X2

Drug: Delzicol

Interventions

IBD98-M: DRUG

single adiministration

Also known as: Mesalamine-Sodium Hyaluronic 400 mg-57.5 mg

Treatment A

IBD98-M without HA DRUG

single adiministration

Also known as: IBD98-M without HA: Mesalamine 400 mg

Treatment B

Delzicol DRUG

single adiministration

Also known as: Mesalamine 400 mg

Treatment C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• the absence of history or known pyloric stenosis.
• the absence of known gastric or duodenal ulcer.
• the absence of urinary tract obstruction.
• Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
• intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration
• condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration
• hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study
• sterile male partner (vasectomized since at least 6 months).
• Capable of consent.

You may not qualify if:

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
• Positive urine drug screen at screening.
• History of allergic reactions to mesalamine, salicylates, aminosalicylates, hyaluronic acid, or other related drugs.
• Positive pregnancy test at screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
• History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and crack) within 1 year prior to screening.
• Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
• Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
• prescription medication within 14 days prior to the first dosing;
• over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
• a depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing.
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
• Hemoglobin \<128 g/L (males) and \<115 g/L (females) and hematocrit \<0.37 L/L (males) and \<0.32 L/L (females) at screening.

Sponsors & Collaborators

• Holy Stone Healthcare Co., Ltd: lead

Study Sites (1)

inVentiv Health Clinique

Québec, Quebec, G1P0A2, Canada

Location

MeSH Terms

Interventions

Mesalamine

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Denis Audet, M.D.

  inVentiv

  PRINCIPAL INVESTIGATOR

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: July 15, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

CA (1)