| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To evaluate the comparative bioavailability between:
•Raltegravir/lamivudine (MK-0518B) 300 mg/150 mg Fixed-Dose Combination (FDC) tablets from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA and
•ISENTRESS® 400 mg tablets from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA co-administered with EPIVIR® 150 mg tablets from ViiV Healthcare UK Limited, United Kingdom after a single-dose in healthy subjects under fasting conditions.
|
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1)Healthy, non-smoking, male or female subjects, from 18 to 55 years of age.
2)BMI ≥ 18.5 and ≤ 30.0 kg/m2.
3)No clinically significant findings in vital signs measurements, laboratory values, 12-lead electrocardiogram (ECG) and physical examination.
4)Have no significant diseases.
5)Males who participate in this study are willing to:
•remain abstinent [not engage in sexual intercourse] from drug administration until 28 days after the end of the study or
•use (or their partner will use, as applicable) two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, vasectomy, or hormonal contraceptives] from drug administration until 28 days after the end of the study.
Females who participate in this study are:
•unable to have children (for example, post-menopausal, hysterectomy);
•willing to remain abstinent [not engage in sexual intercourse] from 21 days prior to drug administration until 28 days after the end of the study; or
•willing to use two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, partner has vasectomy, hormonal contraceptives for 3 months prior to drug administration] from 21 days prior to drug administration until 28 days after the end of the study. |
|
| E.4 | Principal exclusion criteria |
1)Known or suspected carcinoma.
2)Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years.
3)An estimated creatinine clearance of ≤ 80 mL/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of, or in conjunction with, the Cockcroft-Gault equation; subjects who have an actual or estimated creatinine clearance within 10% below 80 mL/min may be enrolled at the discretion of the investigator.
4)A history of liver disease, including chronic hepatitis, or elevated liver enzymes above normal limits at screening.
5)Presence of clinically significant gastrointestinal disease (e.g. peptic ulcer disease or gastric surgery) or history of malabsorption within the last year.
6)Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
7)History of drug or alcohol addiction requiring treatment.
8)Positive test result for serum hCG consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody.
9)Positive test result for urine drugs of abuse or urine cotinine.
10)Females who are lactating.
11)Does not tolerate venipuncture.
12)Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
13)On a special diet within 30 days prior to drug administration (for example, liquid, protein, raw food diet).
14)Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
15)Donation or loss of whole blood:
•≥ 50 mL and ≤ 499 mL within 30 days prior to drug administration
•≥ 500 mL within 56 days prior to drug administration.
16)Females who have started taking hormonal contraceptives or have changed their method or brand of hormonal birth control within 3 months prior to drug administration.
17)Have had a tattoo or body piercing within 30 days prior to drug administration.
18)History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
19)Known history or presence of hypersensitivity or idiosyncratic reaction to raltegravir, lamivudine or any other drug substances with similar activity. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The in vivo performance of this raltegravir/lamivudine FDC tablet assessed by comparing the pharmacokinetics (e.g., AUCt, AUCinf, Cmax, C12 as appropriate) of raltegravir and lamivudine after administration of the FDC tablets and co-administration of raltegravir and lamivudine innovator products as individual tablets. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Prior to dosing (0-hour) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after drug administration |
|
| E.5.2 | Secondary end point(s) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | Yes |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | Yes |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
| E.8.4 | Will this trial be conducted at multiple sites globally? | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 10 |
Print
