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The study employs two-sub-studies that share a common placebo arm.
The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt export pump (BSEP) in the liver, which excretes pravastatin and chenodeoxycholic acid from the liver into the bile.
The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir, chenodeoxycholic acid, and enalaprilat pharmacokinetics. We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine, which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 (PepT1) and apical sodium-bile acid transporter (ASBT), respectively. Enalaprilat is passively absorbed but with low permeability, and thus serves as a passive absorption reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo, then metformin, then polysorbate 80 | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| metformin, then polysorbate 80, then placebo | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| polysorbate 80, then placebo, then metformin | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| polysorbate 80, then metformin, then placebo | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pravastatin and chenodeoxycholic acid, after metformin and placebo | Drug | single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area-Under-the-Curve (AUC) of Pravastatin After Metformin | Pravastatin AUC after metformin, compared to pravastatin AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Pravastatin After Metformin | Pravastatin Cmax after metformin, compared to pravastatin Cmax after placebo. Cmax units are concentration (i.e. ng/ml). | 0-10 hours |
| Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid After Metformin | Baseline-corrected chenodeoxycholic acid AUC after metformin. AUC Units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid After Metformin | Baseline-corrected chenodeoxycholic acid Cmax after metformin. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | 0-10 hours |
| Area-Under-the-Curve (AUC) of Acyclovir After Polysorbate 80 | Acyclovir AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Acyclovir After Polysorbate 80 | Acyclovir Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). | 0-10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Polysorbate 80 | For each of 15 endogenous bile acid, endogenous bile acid AUC after polysorbate 80, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
UMB IRB, a subject is enrolled if they signed a consent form, regardless if they passed screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Metformin, Then Polysorbate 80 | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2021 |
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| placebo, then polysorbate 80, then metformin | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| metformin, then placebo, then polysorbate 80 | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
|
| valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo | Drug | single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
|
| Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80 | Baseline-corrected Chenodeoxycholic acid AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80 | Baseline-corrected Chenodeoxycholic acid Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | 0-10 hours |
| Area-Under-the-Curve (AUC) of Enalaprilat After Polysorbate 80 | Enalaprilat AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Enalaprilat After Polysorbate 80 | Enalaprilat Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). | 0-10 hours |
For each of 15 endogenous bile acid, endogenous bile acid Cmax after metformin, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml). |
| 0-10 hours |
| Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Metformin | For each of 15 endogenous bile acid, endogenous bile acid AUC after metformin, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | 0-10 hours |
| Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Polysorbate 80 | For each of 15 endogenous bile acid, endogenous bile acid Cmax after polysorbate 80, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml). | 0-10 hours |
| FG001 | Metformin, Then Polysorbate 80, Then Placebo | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| FG002 | Polysorbate 80, Then Placebo, Then Metformin | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| FG003 | Polysorbate 80, Then Metformin, Then Placebo | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| FG004 | Placebo, Then Polysorbate 80, Then Metformin | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| FG005 | Metformin, Then Placebo, Then Polysorbate 80 | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| COMPLETED |
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| NOT COMPLETED |
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Dropped participants did not contribute to the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Metformin, Then Polysorbate 80 | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG001 | Metformin, Then Polysorbate 80, Then Placebo | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG002 | Polysorbate 80, Then Placebo, Then Metformin | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG003 | Polysorbate 80, Then Metformin, Then Placebo | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG004 | Placebo, Then Polysorbate 80, Then Metformin | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG005 | Metformin, Then Placebo, Then Polysorbate 80 | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day pravastatin and chenodeoxycholic acid, after metformin and placebo: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area-Under-the-Curve (AUC) of Pravastatin After Metformin | Pravastatin AUC after metformin, compared to pravastatin AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | Posted | Mean | Standard Error | ng/ml × h | 0-10 hours |
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| Primary | Peak Plasma Concentration (Cmax) of Pravastatin After Metformin | Pravastatin Cmax after metformin, compared to pravastatin Cmax after placebo. Cmax units are concentration (i.e. ng/ml). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Primary | Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid After Metformin | Baseline-corrected chenodeoxycholic acid AUC after metformin. AUC Units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Primary | Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid After Metformin | Baseline-corrected chenodeoxycholic acid Cmax after metformin. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Primary | Area-Under-the-Curve (AUC) of Acyclovir After Polysorbate 80 | Acyclovir AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Primary | Peak Plasma Concentration (Cmax) of Acyclovir After Polysorbate 80 | Acyclovir Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Primary | Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80 | Baseline-corrected Chenodeoxycholic acid AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Primary | Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80 | Baseline-corrected Chenodeoxycholic acid Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Primary | Area-Under-the-Curve (AUC) of Enalaprilat After Polysorbate 80 | Enalaprilat AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Primary | Peak Plasma Concentration (Cmax) of Enalaprilat After Polysorbate 80 | Enalaprilat Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Secondary | Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Polysorbate 80 | For each of 15 endogenous bile acid, endogenous bile acid AUC after polysorbate 80, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Secondary | Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Metformin | For each of 15 endogenous bile acid, endogenous bile acid Cmax after metformin, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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| Secondary | Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Metformin | For each of 15 endogenous bile acid, endogenous bile acid AUC after metformin, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h). | Posted | Mean | Standard Error | ng/ml x h | 0-10 hours |
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| Secondary | Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Polysorbate 80 | For each of 15 endogenous bile acid, endogenous bile acid Cmax after polysorbate 80, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml). | Posted | Mean | Standard Error | ng/ml | 0-10 hours |
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Approximately 6 weeks, which is the duration of participant participation in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Participants took 500 mg metformin for 6 days. On day 7, participants were administered the cocktail, which included 80 mg pravastatin and 250 mg CDCA. | 0 | 13 | 0 | 13 | 8 | 13 |
| EG001 | Polysorbate 80 | Participants took 400 mg polysorbate 80 b.i.d. for 6 days. On day 7, participants were administered the cocktail, which included 500 mg valacyclovir, 250 mg CDCA, 20 mg enalaprilat, and 400 mg polysorbate 80. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG002 | Placebo | Participants took one placebo b.i.d. for 6 days. On day 7, participants were administered the cocktail, which included 500 mg valacyclovir, 250 mg CDCA, 20 mg enalaprilat, and 80 mg pravastatin. | 0 | 13 | 0 | 13 | 4 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Lightheaded and vision tunneling | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Elevated liver function tests | Hepatobiliary disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Vasovasgal syncope | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Easy bowel movement | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Stomach discomfort and uneasiness | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Stomach ache/pain | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Stomach cramping | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Mildly elevated alanine aminotransferase | Hepatobiliary disorders | CTCAE Version 5.0 | Systematic Assessment |
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| GI issues (tightness and not feeling regular) | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Abdominal tightness | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Wet/runny stool | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Itchy rash | Skin and subcutaneous tissue disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Polli | University of Maryland, Baltimore | 410-465-3466 | jpolli@rx.umaryland.edu |
| Oct 11, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C535934 | Cholestasis, progressive familial intrahepatic 2 |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D002635 | Chenodeoxycholic Acid |
| D000077483 | Valacyclovir |
| D015773 | Enalaprilat |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D002757 | Cholanes |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004656 | Enalapril |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black/African American |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Asian |
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