AzTrials
AzTrials

CoughPhase 1NCT02157649

Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

A Phase 1 study testing IR Tablet under Fasted conditions, ER Tablet under Fed Conditions and ER Tablet under Fasted Conditions 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 study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of… 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?
IR Tablet under Fasted conditions, ER Tablet under Fed Conditions and ER Tablet under Fasted Conditions
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteJordan
Study dates
Jun 2014to Sep 2014
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;
  • 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 10Show 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) yearNormal 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, caffeine, or xanthine beverages 16 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, Single-Dose, Crossover Comparative Bioavailability and Pharmacokinetic Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet With Immediate-Release Tablet

The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.

Conditions
Cough
Being tested
IR Tablet under Fasted conditions, ER Tablet under Fed Conditions, ER Tablet under Fasted Conditions
Medical subject headings
Cough

What participants receive

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

  • IR Tablet under Fasted conditionsDrug

    Also called Codeine Phosphate/Guaifenesin 20mg/400mg

    Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.

  • ER Tablet under Fed ConditionsDrug

    Also called Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet

    Administration of two ER Tablet combination of Codeine Phosphate/Guaifenesin 30mg/600mg

  • ER Tablet under Fasted ConditionsDrug

    Also called Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet

    Administration of two Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablets under fasted conditions.

Study groups in NCT02157649
Study groupRoleWhat they receive
ER Tablet under Fasted ConditionsExperimentalAdministration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, to subjects under fasted conditions.
Receives: Drug: ER Tablet under Fasted Conditions
IR Tablet under Fasted conditionsActive comparatorIR Tablet combination tablet of Codeine/Guaifenesin 20mg/400mg administered under fasted conditions as a single tablet every 4 hours during a 12 hour study [three doses]
Receives: Drug: IR Tablet under Fasted conditions
ER Tablet under Fed ConditionsExperimentalAdministration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, following a standard high-fat breakfast.
Receives: Drug: ER Tablet under Fed Conditions

What is being measured

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

  1. Serum Levels of Codeine and Guaifenesin

    Blood samples drawn prior to dosing with tablets, then at 19 additional time points over the next 24 hours.

    Measured: 20 samples over 24 hours

Secondary outcomes (1)

  1. Safety and Tolerability

    Collect adverse event data during the dosing and sampling intervals

    Measured: 24 hours

Timeline

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

  1. First posted6 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2014
  4. Study completionSep 2014

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
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02157649
Sponsor's protocol ID
COGU506
Status last verified
Apr 2015
First submitted
4 Jun 2014
Last updated
15 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IR Tablet under Fasted conditions, ER Tablet under Fed Conditions and ER Tablet under Fasted Conditions 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 10 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 15 Apr 2015. 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?

Serum Levels of Codeine and Guaifenesin (time frame: 20 samples over 24 hours). 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 NCT02157649.

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 15 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in