AzTrials
AzTrials

CoughPhase 1COGUSSNCT02572375

Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study

A Phase 1 study testing Codeine Phosphate/Guaifenesin ER Tablet and Codeine Phosphate/Guaifenesin IR Tablet in people with Cough, run by Nexgen Pharma, Inc at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objectives of this pivotal study are: 1. to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration 2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cough
What is being tested?
Codeine Phosphate/Guaifenesin ER Tablet and Codeine Phosphate/Guaifenesin IR Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteJordan
Study dates
Oct 2014to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy non-smoking volunteers (Female volunteers on a stable contraceptive medication regimen (> 3 months) may continue during the course of the study but its use must be documented), 18 to 45 years of age, inclusive; Ethnic Group: Arab \& Mediterranean.
  • Race: Mixed skin (white \& black skin people).
  • Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive (minimum of 50 kg weight);
  • willing and able to comply with the appropriate instructions necessary to complete the study, and;
  • Fully informed of the risks of entering the study and willing to provide written informed consent.
  • Subject is available for the whole study period and gave written informed consent
Show all 11Show fewer
  • If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control [continuously used for at least 3 months before first dose], or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they have been post - menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) for more than one (1) year
  • Normal Physical examination.
  • Vital signs within normal ranges.
  • All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
  • Normal Kidney and Liver functions test.

Who cannot join

  • • Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
  • Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
  • A significant abnormality in the pre-study physical examination that would place the volunteer at risk during participation in the trial;
  • A clinical laboratory test value outside of the accepted reference range that is deemed by the Investigator to be clinically significant;
  • Require prescription medication on a regular basis;
  • A clinically significant illness during the 28 days prior to Period 1 dosing (as determined by the Investigator);
Show all 36Show fewer
  • History of serious illness that can impact fate of drugs
  • History of gastrointestinal obstruction, constipation, inflammatory bowel disease, gallbladder disease, pancreas disorder over last 2 years, or recent (over last 3 years) gastrointestinal tract surgery, including gall bladder resection;
  • Known history or presence of cardiac, pulmonary, endocrine, musculoskeletal, neurological, hematological or disease.
  • Subjects with acute pulmonary insufficiency, respiratory depression, acute or chronic severe respiratory insufficiency or history of any of these
  • History of head injury, seizures over last 4 years deemed by the Investigator to be clinically significant;
  • Mental disease
  • History of kidney disease or urination problem over last 2 years deemed by the Investigator to be clinically significant
  • Subjects with renal and/or hepatic insufficiency should be excluded
  • Presence of any significant physical or organ abnormality
  • History of low blood pressure is deemed by the Investigator to be clinically significant;
  • A positive Hepatitis B surface antigen, Hepatitis C antibody screen, or a reactive HIV antibody screen;
  • Known or suspected hypersensitivities, allergies, or other contraindications to Codeine or a related opioid and/or Guaifenesin;
  • History of severe allergy or allergic reactions to study drug or related drugs or heparin
  • Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • Known or suspected history of drug abuse within lifetime as judged by the Investigator;
  • History of alcohol abuse or excessive intake of alcohol within last 5 years as judged by the Investigator;
  • Positive screen for drugs of abuse, alcohol, or cotinine (nicotine) at screening or on admission to the unit prior to administration of investigational products;
  • Use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 2D6 enzymes, within 30 days prior to administration of study formulations. Examples of inducers include: piperidins, carbamazepine, dexamethasone, rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatine, methadone, and ranitidine;
  • Use of prescription medications within 21 days and OTC medications (including vitamins or herbal products) within 7 days (excluding flu vaccination) prior to the first administration of the study medication without Sponsor approval;
  • Intake of Alcohol 48 before each study drug administration, and caffeine, or xanthine beverages 24 hrs before each study drug administration.
  • Use of any investigational drug within 30 days prior to first dosing;
  • Use of any tobacco-containing product within 6 months of first dosing;
  • Donated more than 400 mL of blood within 4 weeks before first dosing;
  • Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
  • Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
  • Abnormal vital signs
  • Abnormal Kidney and Liver functions test.
  • In the opinion of the Investigator, unlikely or unable to successfully complete the study;
  • Volunteer is vegetarian.
  • Vomiting, Diarrhea on admission.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Pharmaceutical Research Unit

    Amman, 11910

Other trials in Jordan

About this study

Official title: An Open-Label, Randomized, Multiple-Dose, 2-Way Crossover Comparative Bioavailability Steady State Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet in Healthy Subjects

The objectives of this pivotal study are:

  1. to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration
  2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation.
Read the detailed description

This study will be a single-center, Two-site open-label, randomized, multiple-dose, two-treatment, two-period crossover design. During the course of the study, thirty eight (38) healthy adult volunteers will receive multiple doses of Codeine Phosphate/ Guaifenesin extended-release tablet 30 mg/600 mg and multiple doses of an IR Codeine Phosphate/ Guaifenesin immediate-release tablet 20 mg/400 mg tablet in two separate treatment periods.

Volunteers will enter the clinic the day prior [approximately 12 hours] to each dosing and will be confined in the clinic for 7 nights for each treatment period. The extended release tablet (test) will be administered as two tablets two times a day, 12 hours apart, and the immediate release tablet (reference) will be administered as one tablet six times a day, 4 hours apart. Pre-dose blood samples will be collected prior to morning dose on Days 1, 2, 3, 4, 5, 6 and 7. On Day 7, Two extended release tablets will be given once in the morning and the immediate release tablet will be given three times, in the morning and 4 and 8 hours later. Serial blood samples will be collected on Day 7 for up to 12 hours post morning dose.

On Day 7 volunteers will be released from the study site after the 12-hour blood collection if clinically appropriate and will return to the study site to start the next treatment after a minimum of 7 days of wash-out period, which begins the morning after the last dose taken of the previous Period.

Conditions
Cough
Being tested
Codeine Phosphate/Guaifenesin ER Tablet, Codeine Phosphate/Guaifenesin IR Tablet
Medical subject headings
Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Codeine Phosphate/Guaifenesin ER TabletDrug

    Also called Lot 100171

    Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.

  • Codeine Phosphate/Guaifenesin IR TabletDrug

    Also called Lot 100168

    Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days

Study groups in NCT02572375
Study groupRoleWhat they receive
Codeine Phosphate/Guaifenesin ER TabletExperimentalPatients receiving an extended release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin twice a day for 6 and a half days total. Total dosage [2 tablets] is 60 mg Codeine Phosphate and 1200 mg Guaifenesin twice a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.
Receives: Drug: Codeine Phosphate/Guaifenesin ER Tablet
Codeine Phosphate/Guaifenesin IR TabletActive comparatorPatients receiving an immediate release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin six times a day for 6 and a half days total. Dosage is 20 mg Codeine Phosphate and 400 mg Guaifenesin six times a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.
Receives: Drug: Codeine Phosphate/Guaifenesin IR Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax)

    Determination peak plasma concentration of each active ingredient during 12 hours following six days of dosing

    Measured: One week

  2. Area under the plasma concentration versus time curve (AUC)

    Determination of total area under the plasma concentration versus time curve (AUC) during the 12 hours following 6 days of dosing.

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionNov 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572375
Sponsor's protocol ID
COGU510
Acronym
COGUSS
Status last verified
Mar 2017
First submitted
14 Apr 2015
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Codeine Phosphate/Guaifenesin ER Tablet and Codeine Phosphate/Guaifenesin IR Tablet in people with Cough, run by Nexgen Pharma, Inc at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02572375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in